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FDA 510(k)

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE

K-Number: K853049 · 1985-08-02

ApplicantSimmler, Inc.
Decision Date1985-08-02
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1985-08-02 under 510(k) number K853049. 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 FOR ASTRA 8 AUTO STAT/ROUT ANALYZE?

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is Simmler, Inc.. The 510(k) number is K853049.

When did ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE receive FDA 510(k) clearance?

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE received FDA 510(k) clearance on 1985-08-02, under 510(k) number K853049.

Who is the listed applicant for ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE?

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

What is the FDA product code for ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE?

The FDA product code for ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE is CIX.

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Other records listing Simmler, 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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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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