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510(k) K983812

NAPA EIA ASSAY by Diagnostic Reagents, Inc. — Product Code LAN

K983812 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "NAPA EIA ASSAY". The FDA issued a decision of Substantially Equivalent on November 16, 1998. The device falls under product code LAN (Enzyme Immunoassay, N-Acetylprocainamide), a Class II device regulated under 21 CFR 862.3320. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1998
Date Received
October 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, N-Acetylprocainamide
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Diagnostic Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K963835 — DIGOXIN ENZYME IMMUNOASSAY (December 10, 1996)
  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 1996)

Other clearances for product code LAN

  • K060738 — TDM N-ACETYLPROCAINAMIDE (August 16, 2006)
  • K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 (October 31, 2003)
  • K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (June 18, 2001)
  • K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (June 11, 1997)
  • K955422 — AXSYM N-ACETYLPROCAINAMIDE (April 24, 1996)
  • K934705 — OPUS NAPA (November 22, 1993)
  • K922915 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (August 24, 1992)
  • K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (October 25, 1989)
  • K873349 — EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (September 22, 1987)
  • K871680 — MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (June 8, 1987)

FDA data resources