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510(k) K911688

INNOFLUOR(TM) VALPROIC ACID REAGENT SET by Intl. Bioclinical, Inc. — Product Code LEG

K911688 is an FDA 510(k) premarket notification submitted by Intl. Bioclinical, Inc. for the device "INNOFLUOR(TM) VALPROIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 5, 1991. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Intl. Bioclinical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1991
Date Received
April 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Valproic Acid
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

Other clearances by Intl. Bioclinical, Inc.

  • K913187 — INNOFLUOR(TM) DIGITOXIN REAGENT SET (September 23, 1991)
  • K913186 — INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (August 30, 1991)
  • K911466 — INNOFLUOR VALPROIC ACID CALIBRATOR SET (May 23, 1991)
  • K883533 — ABC FP ANALYZER (December 15, 1988)
  • K864156 — PROGESTERONE SYSTEM BY EIA (November 24, 1986)

Other clearances for product code LEG

  • K090358 — ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODE (August 6, 2009)
  • K060690 — ONLINE VALPROIC ACID (August 8, 2006)
  • K042807 — ADVIA IMS VALPROIC ACID METHOD (February 8, 2005)
  • K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT (December 1, 2004)
  • K032049 — ROCHE ONLINE TDM VALPROIC ACID (August 22, 2003)
  • K031870 — SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (July 15, 2003)
  • K030405 — QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (April 28, 2003)
  • K011649 — RANDOX VALPROIC ACID (January 15, 2002)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K002551 — EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019U (October 11, 2000)

FDA data resources