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FDA 510(k)

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST

K-Number: K852286 · 1985-07-09

ApplicantSero-Immuno Diagnostics, Inc.
Decision Date1985-07-09
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sero-Immuno Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852286. 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 DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST?

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is Sero-Immuno Diagnostics, Inc.. The 510(k) number is K852286.

When did DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST receive FDA 510(k) clearance?

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852286.

Who is the listed applicant for DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST?

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

What is the FDA product code for DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST?

The FDA product code for DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST is JHJ.

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Other records listing Sero-Immuno Diagnostics, 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.

K842181BETA-HCG HEMAGGLUTINATION TESTK834328DAT TEST FOR CHAGAS' DISEASE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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