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FDA 510(k)

A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS

K-Number: K864776 · 1986-12-31

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1986-12-31
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS 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 1986-12-31 under 510(k) number K864776. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS?

A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS is a medical device that received FDA 510(k) clearance on 1986-12-31. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K864776.

When did A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS receive FDA 510(k) clearance?

A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS received FDA 510(k) clearance on 1986-12-31, under 510(k) number K864776.

Who is the listed applicant for A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS?

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 A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS?

The FDA product code for A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS is KIR.

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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.

K861172ROTAVIRUS 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 ANTK844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY

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Related Devices (Code: KIR)

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.

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, 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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