FDA 510(k)

CPK1SOENZYMES DETERMINATION PRO. #715-EP

K-Number: K761212 · 1976-12-21

Decision Date1976-12-21

Product CodeJHY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CPK1SOENZYMES DETERMINATION PRO. #715-EP is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1976-12-21 under 510(k) number K761212. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPK1SOENZYMES DETERMINATION PRO. #715-EP?

CPK1SOENZYMES DETERMINATION PRO. #715-EP is a medical device that received FDA 510(k) clearance on 1976-12-21. The listed applicant is Sigma Chemical Co.. The 510(k) number is K761212.

When did CPK1SOENZYMES DETERMINATION PRO. #715-EP receive FDA 510(k) clearance?

CPK1SOENZYMES DETERMINATION PRO. #715-EP received FDA 510(k) clearance on 1976-12-21, under 510(k) number K761212.

Who is the listed applicant for CPK1SOENZYMES DETERMINATION PRO. #715-EP?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPK1SOENZYMES DETERMINATION PRO. #715-EP?

The FDA product code for CPK1SOENZYMES DETERMINATION PRO. #715-EP is JHY.

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Related Devices (Code: JHY)

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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.