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FDA 510(k)

PMK PRIMARY MONKEY KIDNEY-CELLS

K-Number: K842833 · 1984-08-28

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

Device Summary

PMK PRIMARY MONKEY KIDNEY-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 K842833. 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 PMK PRIMARY MONKEY KIDNEY-CELLS?

PMK PRIMARY MONKEY KIDNEY-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 K842833.

When did PMK PRIMARY MONKEY KIDNEY-CELLS receive FDA 510(k) clearance?

PMK PRIMARY MONKEY KIDNEY-CELLS received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842833.

Who is the listed applicant for PMK PRIMARY MONKEY KIDNEY-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 PMK PRIMARY MONKEY KIDNEY-CELLS?

The FDA product code for PMK PRIMARY MONKEY KIDNEY-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.

K842834HEP-2 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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