FDA 510(k)

CARDIOZYME PLUS CK-MB, #65045

K-Number: K821464 · 1982-06-02

Decision Date1982-06-02

Product CodeCGS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CARDIOZYME PLUS CK-MB, #65045 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1982-06-02 under 510(k) number K821464. 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 CARDIOZYME PLUS CK-MB, #65045?

CARDIOZYME PLUS CK-MB, #65045 is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821464.

When did CARDIOZYME PLUS CK-MB, #65045 receive FDA 510(k) clearance?

CARDIOZYME PLUS CK-MB, #65045 received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821464.

Who is the listed applicant for CARDIOZYME PLUS CK-MB, #65045?

The FDA 510(k) record lists Emd Chemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOZYME PLUS CK-MB, #65045?

The FDA product code for CARDIOZYME PLUS CK-MB, #65045 is CGS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.