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FDA 510(k)

RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT

K-Number: K900875 · 1990-03-06

ApplicantReagents Applications, Inc.
Decision Date1990-03-06
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) SPIA(TM) TRANSFERRIN 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 1990-03-06 under 510(k) number K900875. The device is classified under product code DDG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K900875.

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

RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT received FDA 510(k) clearance on 1990-03-06, under 510(k) number K900875.

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

The FDA product code for RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT is DDG.

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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: DDG)

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.

K240987Access sTfRBeckman Coulter, Inc.K190495TransferrinBiosystems S.A.K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo)K120236TRANSFERRIN KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K080634ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495Beckman Coulter, Inc.K081299DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTASiemens Healthcare Diagnostics, 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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