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510(k) K970510

INNOFLOUR TOPIRAMATE REAGENT SET by Oxis Intl., Inc. — Product Code MSL

K970510 is an FDA 510(k) premarket notification submitted by Oxis Intl., Inc. for the device "INNOFLOUR TOPIRAMATE REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 12, 1997. The device falls under product code MSL (System, Test, Topiramatee), a Class II device regulated under 21 CFR 862.3350. Oxis Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1997
Date Received
February 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Topiramatee
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

Other clearances by Oxis Intl., Inc.

  • K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (August 1, 1997)
  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K970509 — INNOFLOUR CALIBRATOR REAGENT SET (May 12, 1997)
  • K955568 — INNOFLUOR QUINIDINE ASSAY SYSTEM (April 4, 1996)
  • K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM (February 9, 1996)
  • K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (February 9, 1996)
  • K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM (January 24, 1996)
  • K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (January 24, 1996)
  • K950346 — B-L RED(TM) DISCS (May 5, 1995)

FDA data resources