FDA 510(k)

CREATININE TEST (CREA) ITEM #65663

K-Number: K884734 · 1988-12-19

Decision Date1988-12-19

Product CodeCGX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CREATININE TEST (CREA) ITEM #65663 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 1988-12-19 under 510(k) number K884734. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE TEST (CREA) ITEM #65663?

CREATININE TEST (CREA) ITEM #65663 is a medical device that received FDA 510(k) clearance on 1988-12-19. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K884734.

When did CREATININE TEST (CREA) ITEM #65663 receive FDA 510(k) clearance?

CREATININE TEST (CREA) ITEM #65663 received FDA 510(k) clearance on 1988-12-19, under 510(k) number K884734.

Who is the listed applicant for CREATININE TEST (CREA) ITEM #65663?

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 CREATININE TEST (CREA) ITEM #65663?

The FDA product code for CREATININE TEST (CREA) ITEM #65663 is CGX.

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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.