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510(k) K860140

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. by American Dade — Product Code LAN

K860140 is an FDA 510(k) premarket notification submitted by American Dade for the device "STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code LAN (Enzyme Immunoassay, N-Acetylprocainamide), a Class II device regulated under 21 CFR 862.3320. American Dade has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1986
Date Received
January 14, 1986
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 American Dade

  • K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (October 20, 1987)
  • K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (September 29, 1987)
  • K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (September 14, 1987)
  • K872789 — PARAMAX URINE/CSF CALIBRATOR (September 2, 1987)
  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

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)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • 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)

FDA data resources