Atlas FDA

LAR

25 FDA 510(k) clearances · Product code

49 daysmedian time to decision
154 days90th percentile
25clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Procainamide
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
ONLINE TDM PROCAINAMIDE (K060773)Roche Diagnostics Corp.2006-08-23
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (K032573)Dade Behring, Inc.2003-10-31
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (K010812)Syva Co., Dade Behring, Inc.2001-04-13
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971716)Bayer Corp.1997-06-27
CEDIA N-ACETYLPROCAINAMIDE ASSAY (K963306)Boehringer Mannheim Corp.1996-10-29
CEDIA PROCAINAMIDE ASSAY (K962099)Boehringer Mannheim Corp.1996-08-27
PROCAINAMIDE ENZYME IMMUNOASSAY (K962463)Diagnostic Reagents, Inc.1996-08-14
ABBOTT AXSM PROCAINAMIDE ASSAY (K955444)Abbott Laboratories1996-04-02
OPUS PROCAINAMIDE (K951434)Behring Diagnostics, Inc.1995-07-03
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847)Roche Diagnostic Systems, Inc.1994-12-02
OPUS PROCAINAMIDE TEST SYSTEM (K934762)Pb Diagnostic Systems, Inc.1994-07-20
EMIT 2000 PROCAINAMIDE CALIBRATORS (K922914)Syva Co.1992-08-24
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 (K873350)Em Diagnostic Systems, Inc.1987-09-29
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. (K860141)American Dade1986-02-11
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR (K852320)Roche Diagnostic Systems, Inc.1985-07-09
EMIT QST PROCAINAMIDE ASSAY (K851061)Syva Co.1985-04-12
TDX PROCAINAMIDE (K834464)Abbott Laboratories1984-02-03
PROCAINAMIDE ANALYTICAL TEST PACK (K833384)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
EMIT CAD PROCAINAMIDE ASSAY (K832718)Syva Co.1983-09-12
AMES TDA PROCAINAMIDE TEST (K831400)Miles Laboratories, Inc.1983-06-02
ADVANCE EMIT CAD PROCAINAMIDE ASSAY (K823128)Syva Co.1982-11-29
EMIT-CAD PROCAINAMIDE ASSAY (K811770)Syva Co.1981-07-10
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY (K811034)Syva Co.1981-05-01
EMIT QUINIDINE ASSAY (K790403)Syva Co.1979-03-21
EMIT PROCAINAMIDE ASSAY (K781382)Syva Co.1978-10-17

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