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FDA 510(k)

AMES SERA-PAK ALBUMIN REAGENT KIT

K-Number: K803237 · 1981-01-09

ApplicantMiles Laboratories, Inc.
Decision Date1981-01-09
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMES SERA-PAK ALBUMIN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-09 under 510(k) number K803237. 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 AMES SERA-PAK ALBUMIN REAGENT KIT?

AMES SERA-PAK ALBUMIN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K803237.

When did AMES SERA-PAK ALBUMIN REAGENT KIT receive FDA 510(k) clearance?

AMES SERA-PAK ALBUMIN REAGENT KIT received FDA 510(k) clearance on 1981-01-09, under 510(k) number K803237.

Who is the listed applicant for AMES SERA-PAK ALBUMIN REAGENT KIT?

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

What is the FDA product code for AMES SERA-PAK ALBUMIN REAGENT KIT?

The FDA product code for AMES SERA-PAK ALBUMIN REAGENT KIT is CIX.

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Other records listing Miles Laboratories, Inc. as applicant

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K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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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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