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FDA 510(k)

GAMMA SLIDE TEST FOR PREGNANCY

K-Number: K832473 · 1983-08-16

ApplicantGamma Biologicals, Inc.
Decision Date1983-08-16
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA SLIDE TEST FOR PREGNANCY is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832473. 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 GAMMA SLIDE TEST FOR PREGNANCY?

GAMMA SLIDE TEST FOR PREGNANCY is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K832473.

When did GAMMA SLIDE TEST FOR PREGNANCY receive FDA 510(k) clearance?

GAMMA SLIDE TEST FOR PREGNANCY received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832473.

Who is the listed applicant for GAMMA SLIDE TEST FOR PREGNANCY?

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

What is the FDA product code for GAMMA SLIDE TEST FOR PREGNANCY?

The FDA product code for GAMMA SLIDE TEST FOR PREGNANCY is JHJ.

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Other records listing Gamma Biologicals, 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.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUSK811752FE-CULT PLUS

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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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