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FDA 510(k)

ONE-STEP HCG

K-Number: K882896 · 1988-10-31

ApplicantWampole Laboratories
Decision Date1988-10-31
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE-STEP HCG is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1988-10-31 under 510(k) number K882896. 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 ONE-STEP HCG?

ONE-STEP HCG is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Wampole Laboratories. The 510(k) number is K882896.

When did ONE-STEP HCG receive FDA 510(k) clearance?

ONE-STEP HCG received FDA 510(k) clearance on 1988-10-31, under 510(k) number K882896.

Who is the listed applicant for ONE-STEP HCG?

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

What is the FDA product code for ONE-STEP HCG?

The FDA product code for ONE-STEP HCG is DHA.

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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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