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FDA 510(k)

REAGENT, ALBUMIN DETERMINATION

K-Number: K760473 · 1976-10-29

ApplicantSimmler & Son, Inc.
Decision Date1976-10-29
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, ALBUMIN DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Simmler & Son, Inc.. It received FDA 510(k) clearance on 1976-10-29 under 510(k) number K760473. 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 REAGENT, ALBUMIN DETERMINATION?

REAGENT, ALBUMIN DETERMINATION is a medical device that received FDA 510(k) clearance on 1976-10-29. The listed applicant is Simmler & Son, Inc.. The 510(k) number is K760473.

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

REAGENT, ALBUMIN DETERMINATION received FDA 510(k) clearance on 1976-10-29, under 510(k) number K760473.

Who is the listed applicant for REAGENT, ALBUMIN DETERMINATION?

The FDA 510(k) record lists Simmler & Son, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT, ALBUMIN DETERMINATION?

The FDA product code for REAGENT, ALBUMIN DETERMINATION is CIX.

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Other records listing Simmler & Son, 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.

K780817GLOBIN-TERGEK771903LIPASEK771905GLYCEROL SUBSTRATEK771904GLYCEROL KINASEK771906PHOSPHATEK761086REAGENTS

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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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