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
K820900Substantially Equivalent

Emit Urine Methadone Assay #3E319

Syva Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820900 is the FDA 510(k) clearance record for EMIT URINE METHADONE ASSAY #3E319, a class I device, cleared for Syva Co. on under FDA product code DDE (Carbonic Anhydrase C, Antigen, Antiserum, Control). FDA records list 212 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K820900.

Clearance record

Decision date
Received
(26 days to decision)
Product code
DDE Carbonic Anhydrase C, Antigen, Antiserum, Control
Regulation
21 CFR 866.5200
Device class
Class I
Review panel
Immunology
Applicant
Syva Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DDE

Trailing 12 months

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

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