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FDA 510(k)

RABBIT KIDNEY CULTURE CELLS (FIRST PASS)

K-Number: K871033 · 1987-03-31

ApplicantMicroscan Div. Baxter Healthcare Corp.
Decision Date1987-03-31
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RABBIT KIDNEY CULTURE CELLS (FIRST PASS) is the device name listed in this FDA 510(k) record. The listed applicant is Microscan Div. Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K871033. 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 RABBIT KIDNEY CULTURE CELLS (FIRST PASS)?

RABBIT KIDNEY CULTURE CELLS (FIRST PASS) is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Microscan Div. Baxter Healthcare Corp.. The 510(k) number is K871033.

When did RABBIT KIDNEY CULTURE CELLS (FIRST PASS) receive FDA 510(k) clearance?

RABBIT KIDNEY CULTURE CELLS (FIRST PASS) received FDA 510(k) clearance on 1987-03-31, under 510(k) number K871033.

Who is the listed applicant for RABBIT KIDNEY CULTURE CELLS (FIRST PASS)?

The FDA 510(k) record lists Microscan Div. Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RABBIT KIDNEY CULTURE CELLS (FIRST PASS)?

The FDA product code for RABBIT KIDNEY CULTURE CELLS (FIRST PASS) is KIR.

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Other records listing Microscan Div. Baxter Healthcare Corp. 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.

K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3K871229ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELLK871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AK871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BK871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1

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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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