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FDA 510(k)

FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY

K-Number: K844105 · 1984-12-06

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-12-06
Product Code
DecisionSubstantially Equivalent

Device Summary

FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY 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 1984-12-06 under 510(k) number K844105. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY?

FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1984-12-06. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K844105.

When did FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1984-12-06, under 510(k) number K844105.

Who is the listed applicant for FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY?

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

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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

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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