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FDA 510(k)

REFLOTRON CREATINE KINASE TEST TABS

K-Number: K904102 · 1990-09-27

ApplicantBoehringer Mannheim Corp.
Decision Date1990-09-27
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOTRON CREATINE KINASE TEST TABS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1990-09-27 under 510(k) number K904102. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOTRON CREATINE KINASE TEST TABS?

REFLOTRON CREATINE KINASE TEST TABS is a medical device that received FDA 510(k) clearance on 1990-09-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K904102.

When did REFLOTRON CREATINE KINASE TEST TABS receive FDA 510(k) clearance?

REFLOTRON CREATINE KINASE TEST TABS received FDA 510(k) clearance on 1990-09-27, under 510(k) number K904102.

Who is the listed applicant for REFLOTRON CREATINE KINASE TEST TABS?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLOTRON CREATINE KINASE TEST TABS?

The FDA product code for REFLOTRON CREATINE KINASE TEST TABS is CGS.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: CGS)

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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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