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FDA 510(k)

CARDIOZYME CK-CONTROL ABNORMAL

K-Number: K770971 · 1977-08-04

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-08-04
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOZYME CK-CONTROL ABNORMAL 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 1977-08-04 under 510(k) number K770971. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOZYME CK-CONTROL ABNORMAL?

CARDIOZYME CK-CONTROL ABNORMAL is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K770971.

When did CARDIOZYME CK-CONTROL ABNORMAL receive FDA 510(k) clearance?

CARDIOZYME CK-CONTROL ABNORMAL received FDA 510(k) clearance on 1977-08-04, under 510(k) number K770971.

Who is the listed applicant for CARDIOZYME CK-CONTROL ABNORMAL?

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

What is the FDA product code for CARDIOZYME CK-CONTROL ABNORMAL?

The FDA product code for CARDIOZYME CK-CONTROL ABNORMAL is JJT.

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

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Related Devices (Code: JJT)

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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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