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510(k) Data Aggregation
K Number
K983860Device Name
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
Manufacturer
Date Cleared
1999-12-27
(420 days)
Product Code
Regulation Number
862.1380Why did this record match?
Product Code :
JMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MTM BioScanner K Test Strips are intended for the quantitative measurement of ketones in capillary whole blood in physicians office labs and at the bedside by professionals and at home by lay users.
Device Description
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K Number
K981865Device Name
MTM BIOSCANNER K TEST STRIPS
Manufacturer
Date Cleared
1999-02-26
(274 days)
Product Code
Regulation Number
862.1380Why did this record match?
Product Code :
JMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MTM Bio Scanner K Test Strip is intended for the in vitro diagnostic quantitative screening for Ketones in whole blood, serum and plasma in physicians' office laboratories and at bedside in acute and convalescent care facilities to screen for ketosis and Diabetic Ketoacidosis.
Device Description
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K Number
K953452Device Name
KETOREX C SANWA
Manufacturer
Date Cleared
1996-05-02
(289 days)
Product Code
Regulation Number
862.1380Why did this record match?
Product Code :
JMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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