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FDA 510(k)

ALBUMIN REAGENT - BROMCRESOL GREEN METHOD

K-Number: K870372 · 1987-08-19

ApplicantTrace Scientific , Ltd.
Decision Date1987-08-19
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT - BROMCRESOL GREEN METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-08-19 under 510(k) number K870372. 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 - BROMCRESOL GREEN METHOD?

ALBUMIN REAGENT - BROMCRESOL GREEN METHOD is a medical device that received FDA 510(k) clearance on 1987-08-19. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K870372.

When did ALBUMIN REAGENT - BROMCRESOL GREEN METHOD receive FDA 510(k) clearance?

ALBUMIN REAGENT - BROMCRESOL GREEN METHOD received FDA 510(k) clearance on 1987-08-19, under 510(k) number K870372.

Who is the listed applicant for ALBUMIN REAGENT - BROMCRESOL GREEN METHOD?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN REAGENT - BROMCRESOL GREEN METHOD?

The FDA product code for ALBUMIN REAGENT - BROMCRESOL GREEN METHOD is CIX.

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Other records listing Trace Scientific , Ltd. 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.

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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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