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FDA 510(k)

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT

K-Number: K810856 · 1981-05-05

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1981-05-05
Product CodeGPT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K810856. The device is classified under product code GPT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT?

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K810856.

When did DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT receive FDA 510(k) clearance?

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT received FDA 510(k) clearance on 1981-05-05, under 510(k) number K810856.

Who is the listed applicant for DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT?

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

What is the FDA product code for DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT?

The FDA product code for DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT is GPT.

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Other records listing Bartels Immunodiagnostic Supplies, 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.

K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSK861172ROTAVIRUS LATEX AGGLUTINATION ASSAYK860279CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITK855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTK842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OFK852185RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT

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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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