AMES TDA/GENTGMICIN— 510(k) K790584

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K790584 for AMES TDA/GENTGMICIN, Substantially Equivalent on 1979-06-15. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1979-03-27
Decision date: 1979-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Recent devices under product code DJB

K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM1983-09-29
K831210 — GENTAMICIN TEST PACK-ACA1983-05-25
K821669 — AMES TDA GENTAMICIN TEST1982-12-15
K812394 — MRI GENTAMICIN RIA KIT1981-09-08
K811844 — COAT-A-COUNT GENTAMICIN RIA KIT1981-07-10

More clearances from Miles Laboratories, Inc.

K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER1988-05-26
K874909 — MICRO-BUMINTEST REAGENT TABLETS1988-04-28
K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE1988-04-05
K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT1987-12-22
K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER1987-10-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.