Atlas FDA

LAN

21 FDA 510(k) clearances · Product code

35 daysmedian time to decision
89 days90th percentile
21clearances measured

FDA profile

Official device name
Enzyme Immunoassay, N-Acetylprocainamide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3320
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
TDM N-ACETYLPROCAINAMIDE (K060738)Roche Diagnostics Corp.2006-08-16
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 (K032564)Dade Behring, Inc.2003-10-31
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (K011620)Syva Co., Dade Behring, Inc.2001-06-18
NAPA EIA ASSAY (K983812)Diagnostic Reagents, Inc.1998-11-16
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971713)Bayer Corp.1997-06-11
AXSYM N-ACETYLPROCAINAMIDE (K955422)Abbott Laboratories1996-04-24
OPUS NAPA (K934705)Pb Diagnostic Systems, Inc.1993-11-22
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (K922915)Syva Co.1992-08-24
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (K895571)Tudor Laboratories, Inc.1989-10-25
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (K873349)Em Diagnostic Systems, Inc.1987-09-22
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (K871680)Roche Diagnostic Systems, Inc.1987-06-08
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. (K860140)American Dade1986-02-06
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I (K853547)American Dade1985-09-16
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS (K852319)Roche Diagnostic Systems, Inc.1985-06-25
EMIT QST N-ACETYLPROCAINAMIDE ASSAY (K851060)Syva Co.1985-04-05
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL (K833378)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS (K832098)Syva Co.1983-08-12
AMES TDA N-ACETYL-PROCAINAMIDE TEST (K831399)Miles Laboratories, Inc.1983-06-02
TDX N-ACETYLPROCAINAMIDE (K830206)Abbott Laboratories1983-02-18
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE (K823129)Syva Co.1982-11-29
EMIT N-ACETYLPROCAINAMIDE ASSAY (K781378)Syva Co.1978-10-10

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Every clearance here is in the API, with alerts when new ones post.