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510(k) Data Aggregation
K Number
K234152Device Name
ACESO Early Pregnancy Test
Manufacturer
Date Cleared
2024-04-05
(98 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
Aceso Laboratories, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ACESO Early Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This device is intended for home-use only.
Device Description
ACESO Early Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to- use format.
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