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FDA 510(k)

RAICHEM (TM)SERUM IRON AND TIBC REAGENTS

K-Number: K864819 · 1987-02-12

ApplicantReagents Applications, Inc.
Decision Date1987-02-12
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM (TM)SERUM IRON AND TIBC 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 1987-02-12 under 510(k) number K864819. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM (TM)SERUM IRON AND TIBC REAGENTS?

RAICHEM (TM)SERUM IRON AND TIBC REAGENTS is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K864819.

When did RAICHEM (TM)SERUM IRON AND TIBC REAGENTS receive FDA 510(k) clearance?

RAICHEM (TM)SERUM IRON AND TIBC REAGENTS received FDA 510(k) clearance on 1987-02-12, under 510(k) number K864819.

Who is the listed applicant for RAICHEM (TM)SERUM IRON AND TIBC 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)SERUM IRON AND TIBC REAGENTS?

The FDA product code for RAICHEM (TM)SERUM IRON AND TIBC REAGENTS is JIY.

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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: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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