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510(k) K860719

BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) by Biotrack, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1986
Date Received
February 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Biotrack, Inc.

  • K934061 — BIOTRACK VALPROIC ACID TEST CARTRIDGE (December 29, 1993)
  • K934062 — BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (December 29, 1993)
  • K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (August 5, 1992)
  • K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE (July 23, 1992)
  • K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (July 23, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)
  • 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)

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