DJD · Class II · 21 CFR 862.3680

FDA Product Code DJD: Enzyme Immunoassay, Primidone

Leading manufacturers include Syva Co., Miles Laboratories, Inc. and Abbott Laboratories.

8
Total
8
Cleared
37d
Avg days
1979
Since

FDA 510(k) Cleared Enzyme Immunoassay, Primidone Devices (Product Code DJD)

8 devices
1–8 of 8
Cleared Mar 14, 1991
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
K910527
Syva Co.
Toxicology · 35d
Cleared Apr 24, 1984
EMIT QST PRIMIDONE ASSAY
K840939
Syva Co.
Toxicology · 50d
Cleared Oct 14, 1983
MODIFICA-OF EMIT AED PRIMIDONE ASSAY
K832798
Syva Co.
Toxicology · 57d
Cleared Jan 28, 1982
PRIMIDONE REAGENT TEST KIT
K820138
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Jan 22, 1982
TDX PRIMIDONE
K813597
Abbott Laboratories
Chemistry · 25d
Cleared Nov 12, 1980
AMES TDA PRIMIDONE TEST
K802654
Miles Laboratories, Inc.
Toxicology · 19d
Cleared Jan 10, 1979
ANALYTICAL TEST PACK, PRIMIDONE
K781957
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d

About Product Code DJD - Regulatory Context