FDA 510(k)

BILIRUBIN STANDARD

K-Number: K882059 · 1988-10-25

Decision Date1988-10-25

Product CodeJIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BILIRUBIN STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Verichem Laboratories, Inc.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K882059. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN STANDARD?

BILIRUBIN STANDARD is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K882059.

When did BILIRUBIN STANDARD receive FDA 510(k) clearance?

BILIRUBIN STANDARD received FDA 510(k) clearance on 1988-10-25, under 510(k) number K882059.

Who is the listed applicant for BILIRUBIN STANDARD?

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

What is the FDA product code for BILIRUBIN STANDARD?

The FDA product code for BILIRUBIN STANDARD is JIT.

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Other records listing Verichem Laboratories, Inc. as applicant

K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES K974290MICROPROTEIN STANDARD KIT K973345MATRIX PLUS MULTI-CALIBRATOR KIT K972333AMMONIA/IRON STANDARD KIT K924904HDL-CHOLESTEROL STANDARD, MODIFICATION K912513ELECTROLYTE CONTROL

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.