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510(k) K890052

BIOTRACK APTT REAGENT CARTRIDGE by Biotrack, Inc. — Product Code GFO

K890052 is an FDA 510(k) premarket notification submitted by Biotrack, Inc. for the device "BIOTRACK APTT REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on February 24, 1989. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Biotrack, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1989
Date Received
January 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
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)
  • 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)

Other clearances for product code GFO

  • K253957 — HemosIL Silica Clotting Time (January 9, 2026)
  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K160445 — HemosIL Silica Clotting Time (March 16, 2016)
  • K053111 — STA-CEPHASCREEN KIT (May 4, 2006)
  • K060688 — HEMOSIL SYNTHASIL (April 13, 2006)
  • K050221 — HEMOSIL SILICA CLOTTING TIME (March 30, 2005)
  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K014028 — CARESIDE APTT (February 8, 2002)
  • K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE (January 24, 2002)
  • K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (December 6, 1999)

FDA data resources