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510(k) K903924

BIOTRACK THEOPHYLLINE QUALITY CONTROLS by Biotrack, Inc. — Product Code LAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1990
Date Received
August 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Theophylline Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Biotrack, Inc.

  • K934062 — BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (December 29, 1993)
  • K934061 — BIOTRACK VALPROIC ACID TEST CARTRIDGE (December 29, 1993)
  • K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (August 5, 1992)
  • K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (July 23, 1992)
  • K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE (July 23, 1992)
  • K900373 — BIOTRACK THEOPHYLLINE TEST CARTRIDGE (May 30, 1990)
  • K900372 — BIOTRACK IMMUNOCHEMISTRY MONITOR (February 23, 1990)
  • K895102 — BIOTRACK PDS MONITOR (October 10, 1989)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)
  • K895128 — BIOTRACK ALT TEST CARTRIDGE (October 6, 1989)

Other clearances for product code LAW

  • K920223 — CHEM CHEX THEOPHYLLINE CONTROL (June 10, 1992)
  • K914251 — MODEL IRC PASSPORT NEBULIZER (January 24, 1992)
  • K871589 — THEOPHYLLINE FPIA CONTROLS (June 17, 1987)