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FDA 510(k)

PREGNANCY TEST KIT

K-Number: K771514 · 1977-09-12

ApplicantGeneric Laboratory, Ltd.
Decision Date1977-09-12
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Generic Laboratory, Ltd.. It received FDA 510(k) clearance on 1977-09-12 under 510(k) number K771514. 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 TEST KIT?

PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1977-09-12. The listed applicant is Generic Laboratory, Ltd.. The 510(k) number is K771514.

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

PREGNANCY TEST KIT received FDA 510(k) clearance on 1977-09-12, under 510(k) number K771514.

Who is the listed applicant for PREGNANCY TEST KIT?

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

What is the FDA product code for PREGNANCY TEST KIT?

The FDA product code for PREGNANCY TEST KIT is JHJ.

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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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