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FDA 510(k)

HEP-2 CELLS

K-Number: K842834 · 1984-08-28

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-08-28
Product CodeKJR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEP-2 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 1984-08-28 under 510(k) number K842834. The device is classified under product code KJR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEP-2 CELLS?

HEP-2 CELLS is a medical device that received FDA 510(k) clearance on 1984-08-28. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K842834.

When did HEP-2 CELLS receive FDA 510(k) clearance?

HEP-2 CELLS received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842834.

Who is the listed applicant for HEP-2 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 HEP-2 CELLS?

The FDA product code for HEP-2 CELLS is KJR.

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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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Related Devices (Code: KJR)

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.

K842833PMK PRIMARY MONKEY KIDNEY-CELLSBartels Immunodiagnostic Supplies, Inc.K792546FETAL CHECKAlta Diagnostics, 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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