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FDA 510(k)

GENERAL DIAGNOSTICS PLATELET ANTIBODY

K-Number: K841465 · 1984-07-02

ApplicantGeneral Diagnostics
Decision Date1984-07-02
Product CodeLLG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENERAL DIAGNOSTICS PLATELET ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1984-07-02 under 510(k) number K841465. The device is classified under product code LLG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL DIAGNOSTICS PLATELET ANTIBODY?

GENERAL DIAGNOSTICS PLATELET ANTIBODY is a medical device that received FDA 510(k) clearance on 1984-07-02. The listed applicant is General Diagnostics. The 510(k) number is K841465.

When did GENERAL DIAGNOSTICS PLATELET ANTIBODY receive FDA 510(k) clearance?

GENERAL DIAGNOSTICS PLATELET ANTIBODY received FDA 510(k) clearance on 1984-07-02, under 510(k) number K841465.

Who is the listed applicant for GENERAL DIAGNOSTICS PLATELET ANTIBODY?

The FDA 510(k) record lists General Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERAL DIAGNOSTICS PLATELET ANTIBODY?

The FDA product code for GENERAL DIAGNOSTICS PLATELET ANTIBODY is LLG.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: LLG)

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.

K840257RAPID IMMUNO-ASSAY SYSApplied Polytechnology, 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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