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FDA 510(k)

MRC-5 CELLS

K-Number: K834126 · 1984-03-22

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-03-22
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MRC-5 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 1984-03-22 under 510(k) number K834126. 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 MRC-5 CELLS?

MRC-5 CELLS is a medical device that received FDA 510(k) clearance on 1984-03-22. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K834126.

When did MRC-5 CELLS receive FDA 510(k) clearance?

MRC-5 CELLS received FDA 510(k) clearance on 1984-03-22, under 510(k) number K834126.

Who is the listed applicant for MRC-5 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 MRC-5 CELLS?

The FDA product code for MRC-5 CELLS is KIR.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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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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