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FDA 510(k)

ENXYMATIC CREATININE TEST

K-Number: K812095 · 1981-08-31

ApplicantBoehringer Mannheim Corp.
Decision Date1981-08-31
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENXYMATIC CREATININE TEST 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 1981-08-31 under 510(k) number K812095. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENXYMATIC CREATININE TEST?

ENXYMATIC CREATININE TEST is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K812095.

When did ENXYMATIC CREATININE TEST receive FDA 510(k) clearance?

ENXYMATIC CREATININE TEST received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812095.

Who is the listed applicant for ENXYMATIC CREATININE TEST?

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 ENXYMATIC CREATININE TEST?

The FDA product code for ENXYMATIC CREATININE TEST is JFY.

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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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