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FDA 510(k)

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT

K-Number: K911898 · 1991-05-08

ApplicantReagents Applications, Inc.
Decision Date1991-05-08
Product CodeDAD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT 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 1991-05-08 under 510(k) number K911898. The device is classified under product code DAD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT?

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1991-05-08. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K911898.

When did RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT receive FDA 510(k) clearance?

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT received FDA 510(k) clearance on 1991-05-08, under 510(k) number K911898.

Who is the listed applicant for RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT?

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) SPIA(TM) HAPTOGLOBIN REAGENT?

The FDA product code for RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT is DAD.

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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: DAD)

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.

K993480K-ASSAY HAPTOGLOBINKamiya Biomedical Co.K972639TINA-QUANT HAPTOGLOBINBoehringer Mannheim Corp.K964301N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.K963286IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTBeckman Instruments, Inc.K952593N/T PROTEIN CONTROL SY/L, M AND HBehring Diagnostics, Inc.K915829IL TEST(TM) HAPTOGLOBIN (HPT)Instrumentation Laboratory CO

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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