510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K982759Substantially Equivalent

Auto-Lyte Cocaine Metabolite Eia, Model # 1222U

OraSure Technologies, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982759 is the FDA 510(k) clearance record for AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U, a class II device, cleared for OraSure Technologies, Inc. on under FDA product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites). FDA records list 30 510(k) clearances for OraSure Technologies, Inc., from to . As of , FDA records show no recalls naming K982759.

Clearance record

Decision date
Received
(106 days to decision)
Product code
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
OraSure Technologies, Inc. 1745 Eaton Ave., Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code DIO

Trailing 12 months

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

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