AMES T-4 STRIP TEST— 510(k) K772014

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K772014 for AMES T-4 STRIP TEST, Substantially Equivalent on 1977-11-02. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1977-10-25
Decision date: 1977-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT1987-12-22
K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER1987-10-28

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