K770974Substantially Equivalent

Cardiozyme Ck-Mb Reagents

Name: K770974 Cardiozyme Ck-Mb Reagents
Creator: Dade, Baxter Travenol Diagnostics, Inc.
Published: 1977-08-26
License: https://open.fda.gov/license/

Dade, Baxter Travenol Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K770974 is the FDA 510(k) clearance record for CARDIOZYME CK-MB REAGENTS, cleared for Dade, Baxter Travenol Diagnostics, Inc. on 1977-08-26. FDA records list 44 510(k) clearances for Dade, Baxter Travenol Diagnostics, Inc., from 1976-08-03 to 1980-03-05. As of 2026-09-10, FDA records show no recalls naming K770974.

Clearance record

Decision date: 1977-08-26
Received: 1977-05-31 (87 days to decision)
Review panel: Unknown
Applicant: Dade, Baxter Travenol Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No