GIZ — Plasma, Control, Normal Class II
FDA product code GIZ covers "Plasma, Control, Normal", a Class II medical device regulated under 21 CFR 864.5425. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GIZ
- Device Class
- Class II
- Regulation Number
- 864.5425
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060968 | wortham laboratories | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; | May 15, 2007 |
| K042941 | dade behring | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | December 2, 2004 |
| K023309 | dade behring | CONTROL PLASMA N | November 1, 2002 |
| K013708 | precision biologic | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | December 10, 2001 |
| K003328 | sigma diagnostics | ACCUCLOT CONTROL I, MODEL A4089 | March 1, 2001 |
| K001256 | dade behring | CONTROL PLASMA N | May 24, 2000 |
| K984129 | pacific hemostasis | COAGULATION CONTROL LEVEL 1 (NORMAL) | December 1, 1998 |
| K973274 | sigma diagnostics | ACCUCOLOR HIGH CALIBRATOR (A3089) | October 31, 1997 |
| K961814 | cardiovascular diagnostics | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | August 13, 1996 |
| K941737 | helena laboratories | SPECIALTY ASSAYED CONTROL-1 | October 7, 1994 |
| K935254 | american diagnostica | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | September 19, 1994 |
| K924403 | behring diagnostics | CONTROL PLASMA N | February 22, 1994 |
| K932145 | american diagnostic | COAGULATION REFERENCE PLASMA, NORMAL | October 18, 1993 |
| K922021 | american bioproducts | UNICALIBRATOR KIT | June 9, 1992 |
| K905203 | medical diagnostic technologies | COAGULATION REFERENCE PLASMA, NORMAL | December 28, 1990 |
| K895262 | medical diagnostic technologies | NORMAL COAGULATION CONTROL PLASMA (NCCP) | October 6, 1989 |
| K893784 | analytical control systems | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | June 23, 1989 |
| K893783 | analytical control systems | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | June 23, 1989 |
| K891179 | elite diagnostic | EDL NORMAL COAGULATION CONTROL | April 10, 1989 |
| K880712 | creative laboratory products | CLP NORMAL COAGULATION CONTROL | May 6, 1988 |