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FDA 510(k)

RAICHEM(TM) BILIRUBIN STANDARD

K-Number: K882726 · 1988-08-29

ApplicantReagents Applications, Inc.
Decision Date1988-08-29
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) BILIRUBIN STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1988-08-29 under 510(k) number K882726. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM(TM) BILIRUBIN STANDARD?

RAICHEM(TM) BILIRUBIN STANDARD is a medical device that received FDA 510(k) clearance on 1988-08-29. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K882726.

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

RAICHEM(TM) BILIRUBIN STANDARD received FDA 510(k) clearance on 1988-08-29, under 510(k) number K882726.

Who is the listed applicant for RAICHEM(TM) BILIRUBIN STANDARD?

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

What is the FDA product code for RAICHEM(TM) BILIRUBIN STANDARD?

The FDA product code for RAICHEM(TM) BILIRUBIN STANDARD is JIS.

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Other records listing Reagents Applications, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982056RAICHEM CO2 REAGENTK972853CHOLESTEROL RAPID LIQUID REAGENTK922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIK915191RAI-TROL ELEVATED LIPIDS CONTROLK913398RAICHEM(TM) CREATINE KINASE-MB REAGENTK911900RAICHEM SPIA C3 REAGENT

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Related Devices (Code: JIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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