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510(k) K971716

PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM by Bayer Corp. — Product Code LAR

K971716 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 1997. The device falls under product code LAR (Enzyme Immunoassay, Procainamide), a Class II device regulated under 21 CFR 862.3320. Bayer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1997
Date Received
May 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Procainamide
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Bayer Corp.

  • K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER (March 3, 2003)
  • K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (February 11, 2003)
  • K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY (January 30, 2003)
  • K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (January 23, 2003)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM (November 20, 2002)
  • K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (July 24, 2002)
  • K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (July 5, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)

Other clearances for product code LAR

  • K060773 — ONLINE TDM PROCAINAMIDE (August 23, 2006)
  • K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (October 31, 2003)
  • K010812 — EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (April 13, 2001)
  • K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAY (October 29, 1996)
  • K962099 — CEDIA PROCAINAMIDE ASSAY (August 27, 1996)
  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 1996)
  • K955444 — ABBOTT AXSM PROCAINAMIDE ASSAY (April 2, 1996)
  • K951434 — OPUS PROCAINAMIDE (July 3, 1995)
  • K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (December 2, 1994)
  • K934762 — OPUS PROCAINAMIDE TEST SYSTEM (July 20, 1994)

FDA data resources