510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801928Substantially Equivalent

Lab-Tek Fta-ABS Kit

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

K801928 is the FDA 510(k) clearance record for LAB-TEK FTA-ABS KIT, a class II device, cleared for Miles Laboratories, Inc. on under FDA product code JWL (Antigen, Treponema Pallidum For Fta-Abs Test). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K801928.

Clearance record

Decision date
Received
(8 days to decision)
Product code
JWL Antigen, Treponema Pallidum For Fta-Abs Test
Regulation
21 CFR 866.3830
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 JWL

Trailing 12 months

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

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