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FDA 510(k)

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST

K-Number: K892654 · 1989-06-19

ApplicantPrinceton Biomedix
Decision Date1989-06-19
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1989-06-19 under 510(k) number K892654. 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 BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST?

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1989-06-19. The listed applicant is Princeton Biomedix. The 510(k) number is K892654.

When did BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST receive FDA 510(k) clearance?

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST received FDA 510(k) clearance on 1989-06-19, under 510(k) number K892654.

Who is the listed applicant for BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST?

The FDA 510(k) record lists Princeton Biomedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST?

The FDA product code for BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST is DHA.

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Other records listing Princeton Biomedix 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.

K942052LIFESIGN MI MYOGLOBINK925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TESTK930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPK925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTK926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTK901011BIOSIGN HCG-ONE STEP PREGNANCY TEST

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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

View on FDA Database →

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

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