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FDA 510(k)

CARDIOZYME CK-MB REAGENTS

K-Number: K770974 · 1977-08-26

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-08-26
Product Code
DecisionSubstantially Equivalent

Device Summary

CARDIOZYME CK-MB REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-08-26 under 510(k) number K770974. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOZYME CK-MB REAGENTS?

CARDIOZYME CK-MB REAGENTS is a medical device that received FDA 510(k) clearance on 1977-08-26. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K770974.

When did CARDIOZYME CK-MB REAGENTS receive FDA 510(k) clearance?

CARDIOZYME CK-MB REAGENTS received FDA 510(k) clearance on 1977-08-26, under 510(k) number K770974.

Who is the listed applicant for CARDIOZYME CK-MB REAGENTS?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Dade, Baxter Travenol Diagnostics, Inc. as applicant

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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.

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