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FDA 510(k)

CK/MB IMMUNO-ISOENZYME CONTROL SERUM

K-Number: K840793 · 1984-04-13

ApplicantSeragen Diagnostics, Inc.
Decision Date1984-04-13
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK/MB IMMUNO-ISOENZYME CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K840793. 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 CK/MB IMMUNO-ISOENZYME CONTROL SERUM?

CK/MB IMMUNO-ISOENZYME CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K840793.

When did CK/MB IMMUNO-ISOENZYME CONTROL SERUM receive FDA 510(k) clearance?

CK/MB IMMUNO-ISOENZYME CONTROL SERUM received FDA 510(k) clearance on 1984-04-13, under 510(k) number K840793.

Who is the listed applicant for CK/MB IMMUNO-ISOENZYME CONTROL SERUM?

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

What is the FDA product code for CK/MB IMMUNO-ISOENZYME CONTROL SERUM?

The FDA product code for CK/MB IMMUNO-ISOENZYME CONTROL SERUM 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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