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FDA 510(k)

STATUS HCG FLUOROMETRIC ENZYME

K-Number: K893577 · 1989-08-03

ApplicantBaxter Healthcare Corp
Decision Date1989-08-03
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATUS HCG FLUOROMETRIC ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K893577. 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 STATUS HCG FLUOROMETRIC ENZYME?

STATUS HCG FLUOROMETRIC ENZYME is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K893577.

When did STATUS HCG FLUOROMETRIC ENZYME receive FDA 510(k) clearance?

STATUS HCG FLUOROMETRIC ENZYME received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893577.

Who is the listed applicant for STATUS HCG FLUOROMETRIC ENZYME?

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

What is the FDA product code for STATUS HCG FLUOROMETRIC ENZYME?

The FDA product code for STATUS HCG FLUOROMETRIC ENZYME is DHA.

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Other records listing Baxter Healthcare Corp as applicant

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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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