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FDA 510(k)

ACU-TEST IN-HOME PREGNANCY TEST

K-Number: K781049 · 1978-06-29

ApplicantWilliams, the J.B. Co., Inc.
Decision Date1978-06-29
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACU-TEST IN-HOME PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Williams, the J.B. Co., Inc.. It received FDA 510(k) clearance on 1978-06-29 under 510(k) number K781049. 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 ACU-TEST IN-HOME PREGNANCY TEST?

ACU-TEST IN-HOME PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1978-06-29. The listed applicant is Williams, the J.B. Co., Inc.. The 510(k) number is K781049.

When did ACU-TEST IN-HOME PREGNANCY TEST receive FDA 510(k) clearance?

ACU-TEST IN-HOME PREGNANCY TEST received FDA 510(k) clearance on 1978-06-29, under 510(k) number K781049.

Who is the listed applicant for ACU-TEST IN-HOME PREGNANCY TEST?

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

What is the FDA product code for ACU-TEST IN-HOME PREGNANCY TEST?

The FDA product code for ACU-TEST IN-HOME PREGNANCY TEST is JHJ.

Related Clinical Trials

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.

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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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