Product code KQG— Hematology
CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
- Classification name
- Instrument, Coagulation
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code KQG
FDA has cleared devices under product code KQG between 1977 and 2005, filed by 11 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
- 2005
- 2002
- 1999
- 1990
- 1986
- 1985
- 1982
- 1979
- 1977
Top applicants under product code KQG
Recent clearances under product code KQG
- K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
- K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
- K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C
- K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200
- K983475 — HEMOCHRON RESPONSE
- K902614 — ELVI 828 DIGICLOT MULTISCAN
- K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
- K862047 — COAGULATOR (8 CHANNEL)
- K852492 — COAGULATOR
- K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER
- K823131 — KOAGULAB 40-A AUTOMATED COAGULATION SYS
- K812906 — ELVI BICLOT 816
- K791587 — ELVI 810 CLOTSCANNER
- K770914 — INCUBATOR, PORTABLE, ACT-STAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.