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FDA 510(k)

SERA-PAK TOTAL PROTEIN REAGENT

K-Number: K802742 · 1980-12-11

ApplicantMiles Laboratories, Inc.
Decision Date1980-12-11
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SERA-PAK TOTAL PROTEIN REAGENT 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 1980-12-11 under 510(k) number K802742. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERA-PAK TOTAL PROTEIN REAGENT?

SERA-PAK TOTAL PROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K802742.

When did SERA-PAK TOTAL PROTEIN REAGENT receive FDA 510(k) clearance?

SERA-PAK TOTAL PROTEIN REAGENT received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802742.

Who is the listed applicant for SERA-PAK TOTAL PROTEIN REAGENT?

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 SERA-PAK TOTAL PROTEIN REAGENT?

The FDA product code for SERA-PAK TOTAL PROTEIN REAGENT is GGK.

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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: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, 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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