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FDA 510(k)

ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17

K-Number: K912807 · 1991-10-31

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-10-31
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K912807. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17?

ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K912807.

When did ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 receive FDA 510(k) clearance?

ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 received FDA 510(k) clearance on 1991-10-31, under 510(k) number K912807.

Who is the listed applicant for ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17?

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

What is the FDA product code for ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17?

The FDA product code for ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 is JFY.

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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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