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FDA 510(k)

ALB BCG REAGENT

K-Number: K852007 · 1985-05-30

ApplicantAlpkem Corp.
Decision Date1985-05-30
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALB BCG REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-30 under 510(k) number K852007. 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 ALB BCG REAGENT?

ALB BCG REAGENT is a medical device that received FDA 510(k) clearance on 1985-05-30. The listed applicant is Alpkem Corp.. The 510(k) number is K852007.

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

ALB BCG REAGENT received FDA 510(k) clearance on 1985-05-30, under 510(k) number K852007.

Who is the listed applicant for ALB BCG REAGENT?

The FDA 510(k) record lists Alpkem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALB BCG REAGENT?

The FDA product code for ALB BCG REAGENT is CIX.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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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