Product code GIT— Hematology

BIOTRACK APTT CONTROLS

Classification name: Reagent & Control, Partial Thromboplastin Time
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Total cleared: 4
First cleared: 1982-03-26
Most recent: 1989-02-23

Market context for product code GIT

FDA has cleared 4 devices under product code GIT between 1982 and 1989, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19891 clearance
19882 clearances
19821 clearance

Top applicants under product code GIT

Pacific Hemostasis1 clearance
Organon Teknika Corp.1 clearance
Creative Laboratory Products, Inc.1 clearance
Biotrack, Inc.1 clearance

Recent clearances under product code GIT

K890051 — BIOTRACK APTT CONTROLSBiotrack, Inc.·1989-02-23
K881999 — PLATELIN(R) EXCEL LOrganon Teknika Corp.·1988-08-17
K880711 — CLP 0.02 M CALCIUM CHLORIDE SOLUTION.Creative Laboratory Products, Inc.·1988-03-18
K820450 — THROMBOSCREENPacific Hemostasis·1982-03-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.