FDA 510(k)

CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02

K-Number: K991109 · 1999-05-25

Decision Date1999-05-25

Product CodeCGX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 is the device name listed in this FDA 510(k) record. The listed applicant is A.P. Total Care, Inc.. It received FDA 510(k) clearance on 1999-05-25 under 510(k) number K991109. 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 REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02?

CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 is a medical device that received FDA 510(k) clearance on 1999-05-25. The listed applicant is A.P. Total Care, Inc.. The 510(k) number is K991109.

When did CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 receive FDA 510(k) clearance?

CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 received FDA 510(k) clearance on 1999-05-25, under 510(k) number K991109.

Who is the listed applicant for CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02?

The FDA 510(k) record lists A.P. Total Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02?

The FDA product code for CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 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.