510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841814Substantially Equivalent

Optimate Igm Test

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

K841814 is the FDA 510(k) clearance record for OPTIMATE IGM TEST, a class II device, cleared for Miles Laboratories, Inc. on under FDA product code DFT (Igm, Antigen, Antiserum, Control). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K841814.

Clearance record

Decision date
Received
(52 days to decision)
Product code
DFT Igm, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Miles Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DFT

Trailing 12 months

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

FDA records show no clearances under product code DFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DFT, 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