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FDA 510(k)

PREGNANCY BETA-HCG CARD & LIQUID TEST

K-Number: K880478 · 1988-04-28

ApplicantAmpcor, Inc.
Decision Date1988-04-28
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY BETA-HCG CARD & LIQUID 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 1988-04-28 under 510(k) number K880478. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREGNANCY BETA-HCG CARD & LIQUID TEST?

PREGNANCY BETA-HCG CARD & LIQUID TEST is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Ampcor, Inc.. The 510(k) number is K880478.

When did PREGNANCY BETA-HCG CARD & LIQUID TEST receive FDA 510(k) clearance?

PREGNANCY BETA-HCG CARD & LIQUID TEST received FDA 510(k) clearance on 1988-04-28, under 510(k) number K880478.

Who is the listed applicant for PREGNANCY BETA-HCG CARD & LIQUID 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 PREGNANCY BETA-HCG CARD & LIQUID TEST?

The FDA product code for PREGNANCY BETA-HCG CARD & LIQUID TEST is JHJ.

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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 SALMONELLAK893873SINGLE AND DUAL BAND DIPSTICK HCG TESTK890048QUIK-DOT TOXOPLASMOSISK892146C REACTIVE PROTEIN LIQUID

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Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, 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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