510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012164Substantially Equivalent

'Rapidone'-Methadone Test

American Bio Medica Corp., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012164 is the FDA 510(k) clearance record for 'RAPIDONE'-METHADONE TEST, a class II device, cleared for American Bio Medica Corp. on under FDA product code DJR (Enzyme Immunoassay, Methadone). FDA records list 30 510(k) clearances for American Bio Medica Corp., from to . As of , FDA records show no recalls naming K012164.

Clearance record

Decision date
Received
(132 days to decision)
Product code
DJR Enzyme Immunoassay, Methadone
Regulation
21 CFR 862.3620
Device class
Class II
Review panel
Clinical Toxicology
Applicant
American Bio Medica Corp. 9110 Red Branch Rd., Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code DJR

Trailing 12 months

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

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