Search Results
Found 4 results
510(k) Data Aggregation
K Number
K051925Device Name
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
Manufacturer
Date Cleared
2005-11-29
(134 days)
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
ACCESS BIO INCORPORATE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CareStart™ Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, CK-MB and myoglobin in human blood, serum qualitative detection of cardiac troponin I, CK-MB and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
CareStart™ Cardiac 2-in-1 Troponin I/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, and myoglobin in human blood, serum or plasma. detooking of cardiae troponin I, and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
CareStart™ Cardiac CKMB Test is intended for the qualitative detection of CK-MB in human blood, serum or plasma. Measurement of CK-MB aids in rapid diagnosis of numan blood, corant of on. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
CareStart™ Cardiac Troponin I Test is intended for the qualitative detection of cardiac oarcotar troponiir in haman broomyocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K032159Device Name
CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
Manufacturer
Date Cleared
2003-09-05
(52 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
ACCESS BIO INCORPORATE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CareStart™ Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for over-the counter sale to laypersons.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K031048Device Name
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
Manufacturer
Date Cleared
2003-06-16
(75 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
ACCESS BIO INCORPORATE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CareStart™ hCG Combo One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K031052Device Name
CARESTART HCG ONE-STEP PREGNANCY TEST
Manufacturer
Date Cleared
2003-06-13
(72 days)
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
ACCESS BIO INCORPORATE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CareStanTM hCG One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1