Atlas FDA

NAPA EIA ASSAY

FDA 510(k) clearance K983812 · decided 1998-11-16

Clearance details

K-number
K983812
Device name
NAPA EIA ASSAY
Applicant
Diagnostic Reagents, Inc.
Decision
Substantially Equivalent
Date received
1998-10-28
Decision date
1998-11-16
Days to decision
19 days
Clearance type
Traditional
Product code
LAN
Device class
2
Regulation number
862.3320
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Diagnostic Reagents

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
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

Recalls involving this device

No recalls on record reference this clearance.