510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821408Substantially Equivalent

Phenobarbital Fluorescent Immuno

American Diagnostic Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821408 is the FDA 510(k) clearance record for PHENOBARBITAL FLUORESCENT IMMUNO, a class II device, cleared for American Diagnostic Corp. on under FDA product code LET (Fluorescent Immunoassay, Phenobarbital). FDA records list 39 510(k) clearances for American Diagnostic Corp., from to . As of , FDA records show no recalls naming K821408.

Clearance record

Decision date
Received
(13 days to decision)
Product code
LET Fluorescent Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
American Diagnostic Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LET

Trailing 12 months

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

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