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FDA 510(k)

ISOZYME - ID CPK MARKER

K-Number: K780801 · 1978-06-13

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1978-06-13
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOZYME - ID CPK MARKER 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 1978-06-13 under 510(k) number K780801. 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 ISOZYME - ID CPK MARKER?

ISOZYME - ID CPK MARKER is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K780801.

When did ISOZYME - ID CPK MARKER receive FDA 510(k) clearance?

ISOZYME - ID CPK MARKER received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780801.

Who is the listed applicant for ISOZYME - ID CPK MARKER?

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 ISOZYME - ID CPK MARKER?

The FDA product code for ISOZYME - ID CPK MARKER is 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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