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FDA 510(k)

STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K922073 · 1992-10-19

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-10-19
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-10-19 under 510(k) number K922073. 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 STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1992-10-19. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922073.

When did STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1992-10-19, under 510(k) number K922073.

Who is the listed applicant for STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY is DHA.

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Other records listing Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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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