FDA 510(k)

SERALYZER AST/SGOT REAGENT STRIPS

K-Number: K832790 · 1983-10-14

Decision Date1983-10-14

Product CodeCIF

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SERALYZER AST/SGOT REAGENT STRIPS 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 1983-10-14 under 510(k) number K832790. The device is classified under product code CIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER AST/SGOT REAGENT STRIPS?

SERALYZER AST/SGOT REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K832790.

When did SERALYZER AST/SGOT REAGENT STRIPS receive FDA 510(k) clearance?

SERALYZER AST/SGOT REAGENT STRIPS received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832790.

Who is the listed applicant for SERALYZER AST/SGOT REAGENT STRIPS?

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 SERALYZER AST/SGOT REAGENT STRIPS?

The FDA product code for SERALYZER AST/SGOT REAGENT STRIPS is CIF.

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Other records listing Miles Laboratories, Inc. as applicant

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER K874909MICRO-BUMINTEST REAGENT TABLETS K875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE K871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT K872120SERALYZER III BLOOD CHEMISTRY ANALYZER K873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.