Product code GIZ— Hematology
CONTROL PLASMA N
- Classification name
- Plasma, Control, Normal
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code GIZ
FDA has cleared devices under product code GIZ between 1988 and 2007, filed by 15 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
- 2007
- 2004
- 2002
- 2001
- 2000
- 1998
- 1997
- 1996
- 1994
- 1993
- 1992
- 1990
- 1989
- 1988
Top applicants under product code GIZ
Recent clearances under product code GIZ
- K060968 — STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
- K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
- K023309 — CONTROL PLASMA N
- K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10
- K003328 — ACCUCLOT CONTROL I, MODEL A4089
- K001256 — CONTROL PLASMA N
- K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL)
- K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089)
- K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
- K941737 — SPECIALTY ASSAYED CONTROL-1
- K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
- K924403 — CONTROL PLASMA N
- K932145 — COAGULATION REFERENCE PLASMA, NORMAL
- K922021 — UNICALIBRATOR KIT
- K905203 — COAGULATION REFERENCE PLASMA, NORMAL
- K895262 — NORMAL COAGULATION CONTROL PLASMA (NCCP)
- K893783 — ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
- K893784 — ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
- K891179 — EDL NORMAL COAGULATION CONTROL
- K880712 — CLP NORMAL COAGULATION CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.