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FDA 510(k)

RAICHEM(TM) SPIA(TM) IGA REAGENTS

K-Number: K894418 · 1989-08-02

ApplicantReagents Applications, Inc.
Decision Date1989-08-02
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) SPIA(TM) IGA REAGENTS 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 1989-08-02 under 510(k) number K894418. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM(TM) SPIA(TM) IGA REAGENTS?

RAICHEM(TM) SPIA(TM) IGA REAGENTS is a medical device that received FDA 510(k) clearance on 1989-08-02. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K894418.

When did RAICHEM(TM) SPIA(TM) IGA REAGENTS receive FDA 510(k) clearance?

RAICHEM(TM) SPIA(TM) IGA REAGENTS received FDA 510(k) clearance on 1989-08-02, under 510(k) number K894418.

Who is the listed applicant for RAICHEM(TM) SPIA(TM) IGA REAGENTS?

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) IGA REAGENTS?

The FDA product code for RAICHEM(TM) SPIA(TM) IGA REAGENTS is CZP.

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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 REAGENTK911899RAICHEM SPIA C4 REAGENT

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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