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FDA 510(k)

UNISTEP HCG PREGNANCY TEST STRIP

K-Number: K941090 · 1994-06-02

ApplicantBiotech Atlantic, Inc.
Decision Date1994-06-02
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNISTEP HCG PREGNANCY TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Atlantic, Inc.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K941090. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISTEP HCG PREGNANCY TEST STRIP?

UNISTEP HCG PREGNANCY TEST STRIP is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Biotech Atlantic, Inc.. The 510(k) number is K941090.

When did UNISTEP HCG PREGNANCY TEST STRIP receive FDA 510(k) clearance?

UNISTEP HCG PREGNANCY TEST STRIP received FDA 510(k) clearance on 1994-06-02, under 510(k) number K941090.

Who is the listed applicant for UNISTEP HCG PREGNANCY TEST STRIP?

The FDA 510(k) record lists Biotech Atlantic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISTEP HCG PREGNANCY TEST STRIP?

The FDA product code for UNISTEP HCG PREGNANCY TEST STRIP is DHA.

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Other records listing Biotech Atlantic, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032992UNIMARK HOME PREGNANCY TEST DEVICEK013194UNIMARK HCG COMBO PREGNANCY TESTK960174UNIMARK MIDSTREAM PREGNANCY TEST STICK

Related Devices (Code: DHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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