510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192517Substantially Equivalent

Psychemedics Microplate EIA for Cotinine in Hair

Psychemedics Corp., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192517 is the FDA 510(k) clearance record for Psychemedics Microplate EIA for Cotinine in Hair, a class I device, cleared for Psychemedics Corporation on under FDA product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites). FDA records list 19 510(k) clearances for Psychemedics Corporation, from to . As of , FDA records show no recalls naming K192517.

Clearance record

Decision date
Received
(222 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
Psychemedics Corporation 5832 Uplander Way, Culver City CA
510(k) summary
Summary PDF
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