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FDA 510(k)

ALBUMIN REAGENT KIT

K-Number: K860213 · 1986-02-11

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1986-02-11
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K860213. 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 KIT?

ALBUMIN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K860213.

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

ALBUMIN REAGENT KIT received FDA 510(k) clearance on 1986-02-11, under 510(k) number K860213.

Who is the listed applicant for ALBUMIN REAGENT KIT?

The FDA 510(k) record lists Bio-Analytics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN REAGENT KIT?

The FDA product code for ALBUMIN REAGENT KIT is CIX.

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Other records listing Bio-Analytics Laboratories, 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK851513ULTRA-VIOLET BUN REAGENT KITK850639ENZYMATIC ALPHA-AMYLASE REAGENT KITK832771ERYTHROCYTE TEST

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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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