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510(k) K973582

ACE PRIMIDONE REAGENT, AED CALIBRATORS by Schiapparelli Biosystems, Inc. — Product Code DJD

K973582 is an FDA 510(k) premarket notification submitted by Schiapparelli Biosystems, Inc. for the device "ACE PRIMIDONE REAGENT, AED CALIBRATORS". The FDA issued a decision of Substantially Equivalent on November 12, 1997. The device falls under product code DJD (Enzyme Immunoassay, Primidone), a Class II device regulated under 21 CFR 862.3680. Schiapparelli Biosystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1997
Date Received
September 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Primidone
Device Class
Class II
Regulation Number
862.3680
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)
  • 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)
  • K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (October 20, 1997)
  • K971526 — ACE HDL-C REAGENT (May 21, 1997)
  • K954179 — HDL PRECIPITATING REAGENT (December 11, 1995)

Other clearances for product code DJD

  • K910527 — EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE (March 14, 1991)
  • K840939 — EMIT QST PRIMIDONE ASSAY (April 24, 1984)
  • K832798 — MODIFICA-OF EMIT AED PRIMIDONE ASSAY (October 14, 1983)
  • K820138 — PRIMIDONE REAGENT TEST KIT (January 28, 1982)
  • K813597 — TDX PRIMIDONE (January 22, 1982)
  • K802654 — AMES TDA PRIMIDONE TEST (November 12, 1980)
  • K781957 — ANALYTICAL TEST PACK, PRIMIDONE (January 10, 1979)

FDA data resources