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FDA 510(k)

TOTAL PROTEIN (URINE)

K-Number: K951222 · 1996-04-24

ApplicantRandox Laboratories, Ltd.
Decision Date1996-04-24
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN (URINE) is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1996-04-24 under 510(k) number K951222. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL PROTEIN (URINE)?

TOTAL PROTEIN (URINE) is a medical device that received FDA 510(k) clearance on 1996-04-24. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K951222.

When did TOTAL PROTEIN (URINE) receive FDA 510(k) clearance?

TOTAL PROTEIN (URINE) received FDA 510(k) clearance on 1996-04-24, under 510(k) number K951222.

Who is the listed applicant for TOTAL PROTEIN (URINE)?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL PROTEIN (URINE)?

The FDA product code for TOTAL PROTEIN (URINE) is JIR.

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Related Devices (Code: JIR)

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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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