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FDA 510(k)

AMES SERA-PAK CHOLESTEROL REAGENT KIT

K-Number: K802743 · 1980-12-10

ApplicantMiles Laboratories, Inc.
Decision Date1980-12-10
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMES SERA-PAK CHOLESTEROL 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 1980-12-10 under 510(k) number K802743. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES SERA-PAK CHOLESTEROL REAGENT KIT?

AMES SERA-PAK CHOLESTEROL REAGENT KIT is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K802743.

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

AMES SERA-PAK CHOLESTEROL REAGENT KIT received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802743.

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

The FDA product code for AMES SERA-PAK CHOLESTEROL REAGENT KIT is CHH.

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Other records listing Miles 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.

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: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.

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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