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FDA 510(k)

DIRECT PREGNANCY TEST

K-Number: K920716 · 1992-03-24

ApplicantTech-Co, Inc.
Decision Date1992-03-24
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1992-03-24 under 510(k) number K920716. 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 DIRECT PREGNANCY TEST?

DIRECT PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1992-03-24. The listed applicant is Tech-Co, Inc.. The 510(k) number is K920716.

When did DIRECT PREGNANCY TEST receive FDA 510(k) clearance?

DIRECT PREGNANCY TEST received FDA 510(k) clearance on 1992-03-24, under 510(k) number K920716.

Who is the listed applicant for DIRECT PREGNANCY TEST?

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

What is the FDA product code for DIRECT PREGNANCY TEST?

The FDA product code for DIRECT PREGNANCY TEST is JHJ.

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Other records listing Tech-Co, 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITYK883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)

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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.K910946CLEARVIEW HCGUnipath , Ltd.

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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