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FDA 510(k)

ALBUMIN REAGENT (BCG

K-Number: K831585 · 1983-06-16

ApplicantReagents Applications, Inc.
Decision Date1983-06-16
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT (BCG 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 1983-06-16 under 510(k) number K831585. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN REAGENT (BCG?

ALBUMIN REAGENT (BCG is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K831585.

When did ALBUMIN REAGENT (BCG receive FDA 510(k) clearance?

ALBUMIN REAGENT (BCG received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831585.

Who is the listed applicant for ALBUMIN REAGENT (BCG?

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 ALBUMIN REAGENT (BCG?

The FDA product code for ALBUMIN REAGENT (BCG is CIX.

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Other records listing Reagents Applications, Inc. as applicant

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Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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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