510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972481Substantially Equivalent

Auto-Lyte Cotinine Eia

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

K972481 is the FDA 510(k) clearance record for AUTO-LYTE COTININE EIA, a class I device, cleared for OraSure Technologies, Inc. on under FDA product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites). FDA records list 30 510(k) clearances for OraSure Technologies, Inc., from to . As of , FDA records show no recalls naming K972481.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Applicant
OraSure Technologies, Inc. 1745 Eaton Ave., Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code MKU

Trailing 12 months

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

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