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FDA 510(k)

RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD

K-Number: K883389 · 1988-12-14

ApplicantReagents Applications, Inc.
Decision Date1988-12-14
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) BILIRUBIN CONJUGATE 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 1988-12-14 under 510(k) number K883389. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD?

RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD is a medical device that received FDA 510(k) clearance on 1988-12-14. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K883389.

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

RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD received FDA 510(k) clearance on 1988-12-14, under 510(k) number K883389.

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

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

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Other records listing Reagents Applications, Inc. as applicant

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Related Devices (Code: JIW)

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.

K973055WAKO CH50 LINEARITY SETWako Chemicals USA, Inc.K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITSigma Diagnostics, Inc.K902575SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.K902294ACCUSCAN MICROBEAD STANDARDSSigma Chemical Co.K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.

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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