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510(k) K973535

ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS by Schiapparelli Biosystems, Inc. — Product Code KLT

K973535 is an FDA 510(k) premarket notification submitted by Schiapparelli Biosystems, Inc. for the device "ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS". The FDA issued a decision of Substantially Equivalent on October 20, 1997. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Schiapparelli Biosystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
September 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Schiapparelli Biosystems, Inc.

  • K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (July 13, 1999)
  • K981377 — ACE T4 REAGENT T4 CALIBRATORS (June 10, 1998)
  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K973581 — ACE VALPROIC ACID REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K973536 — ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (November 6, 1997)
  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K971526 — ACE HDL-C REAGENT (May 21, 1997)
  • K954179 — HDL PRECIPITATING REAGENT (December 11, 1995)

Other clearances for product code KLT

  • K151578 — Carbamazepine Gen 4 (October 22, 2015)
  • K123518 — ABBOTT CARBAMAZEPINE ASSAY (June 5, 2013)
  • K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIB (October 14, 2011)
  • K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (October 5, 2007)
  • K042808 — ADVIA IMS CARBAMAZEPINE METHOD (February 8, 2005)
  • K031902 — ONLINE TDM CARBAMAZEPINE (September 17, 2003)
  • K011648 — RANDOX CARBAMAZEPINE (January 15, 2002)
  • K010814 — EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (April 13, 2001)
  • K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (May 18, 2000)
  • K000007 — IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2 (February 28, 2000)

FDA data resources