510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830758Substantially Equivalent

Azlin Azlocilin Sodium-Diag. Reagent

Miles Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830758 is the FDA 510(k) clearance record for AZLIN AZLOCILIN SODIUM-DIAG. REAGENT, a class II device, cleared for Miles Laboratories, Inc. on under FDA product code JTT (Susceptibility Test Powders, Antimicrobial). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K830758.

Clearance record

Decision date
Received
(76 days to decision)
Product code
JTT Susceptibility Test Powders, Antimicrobial
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Miles Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTT

Trailing 12 months

FDA records hold no clearances under product code JTT in the trailing twelve months.

FDA records show no clearances under product code JTT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JTT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260