LAN · Class II · 21 CFR 862.3320

FDA Product Code LAN: Enzyme Immunoassay, N-acetylprocainamide

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

21
Total
21
Cleared
51d
Avg days
1978
Since

FDA 510(k) Cleared Enzyme Immunoassay, N-acetylprocainamide Devices (Product Code LAN)

21 devices
1–21 of 21
Cleared Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
K060738
Roche Diagnostics Corp.
Toxicology · 149d
Cleared Oct 31, 2003
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564
Dade Behring, Inc.
Chemistry · 72d
Cleared Apr 24, 1996
AXSYM N-ACETYLPROCAINAMIDE
K955422
Abbott Laboratories
Toxicology · 148d
Cleared Aug 24, 1992
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915
Syva Co.
Toxicology · 68d
Cleared Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349
Em Diagnostic Systems, Inc.
Toxicology · 33d
Cleared Jun 08, 1987
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
K871680
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Jun 25, 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
K852319
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Apr 05, 1985
EMIT QST N-ACETYLPROCAINAMIDE ASSAY
K851060
Syva Co.
Toxicology · 21d
Cleared Dec 27, 1983
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
K833378
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Aug 12, 1983
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS
K832098
Syva Co.
Chemistry · 44d
Cleared Feb 18, 1983
TDX N-ACETYLPROCAINAMIDE
K830206
Abbott Laboratories
Chemistry · 28d
Cleared Nov 29, 1982
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE
K823129
Syva Co.
Chemistry · 35d
Cleared Oct 10, 1978
EMIT N-ACETYLPROCAINAMIDE ASSAY
K781378
Syva Co.
Toxicology · 61d

About Product Code LAN - Regulatory Context