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FDA 510(k)

PREGNANCY (HCG) CARD & LIQUID TEST

K-Number: K880163 · 1988-05-17

ApplicantAmpcor, Inc.
Decision Date1988-05-17
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY (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 1988-05-17 under 510(k) number K880163. 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 (HCG) CARD & LIQUID TEST?

PREGNANCY (HCG) CARD & LIQUID TEST is a medical device that received FDA 510(k) clearance on 1988-05-17. The listed applicant is Ampcor, Inc.. The 510(k) number is K880163.

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

PREGNANCY (HCG) CARD & LIQUID TEST received FDA 510(k) clearance on 1988-05-17, under 510(k) number K880163.

Who is the listed applicant for PREGNANCY (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 (HCG) CARD & LIQUID TEST?

The FDA product code for PREGNANCY (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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