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FDA 510(k)

SINGLE AND DUAL BAND DIPSTICK HCG TEST

K-Number: K893873 · 1989-08-21

ApplicantAmpcor, Inc.
Decision Date1989-08-21
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE AND DUAL BAND DIPSTICK HCG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ampcor, Inc.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K893873. 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 SINGLE AND DUAL BAND DIPSTICK HCG TEST?

SINGLE AND DUAL BAND DIPSTICK HCG TEST is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Ampcor, Inc.. The 510(k) number is K893873.

When did SINGLE AND DUAL BAND DIPSTICK HCG TEST receive FDA 510(k) clearance?

SINGLE AND DUAL BAND DIPSTICK HCG TEST received FDA 510(k) clearance on 1989-08-21, under 510(k) number K893873.

Who is the listed applicant for SINGLE AND DUAL BAND DIPSTICK HCG TEST?

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

What is the FDA product code for SINGLE AND DUAL BAND DIPSTICK HCG TEST?

The FDA product code for SINGLE AND DUAL BAND DIPSTICK HCG TEST is DHA.

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Other records listing Ampcor, 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.

K922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TESTK922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TESTK910438DIPSTICK SALMONELLAK890048QUIK-DOT TOXOPLASMOSISK892119QUIK-DOT C REACTIVE PROTEINK892146C REACTIVE PROTEIN LIQUID

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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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