Atlas FDA

AXSYM N-ACETYLPROCAINAMIDE

FDA 510(k) clearance K955422 · decided 1996-04-24

Clearance details

K-number
K955422
Device name
AXSYM N-ACETYLPROCAINAMIDE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1995-11-28
Decision date
1996-04-24
Days to decision
148 days
Clearance type
Traditional
Product code
LAN
Device class
2
Regulation number
862.3320
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30