Product code GIZ
- Device name
- Plasma, Control, Normal
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5425
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060968 | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW | Wortham Laboratories, Inc. | 2007-05-15 |
| K042941 | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | 2004-12-02 |
| K023309 | CONTROL PLASMA N | Dade Behring, Inc. | 2002-11-01 |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | 2001-12-10 |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | 2001-03-01 |
| K001256 | CONTROL PLASMA N | Dade Behring, Inc. | 2000-05-24 |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | 1998-12-01 |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | 1997-10-31 |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Cardiovascular Diagnostics, Inc. | 1996-08-13 |
| K941737 | SPECIALTY ASSAYED CONTROL-1 | Helena Laboratories | 1994-10-07 |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | American Diagnostica, Inc. | 1994-09-19 |
| K924403 | CONTROL PLASMA N | Behring Diagnostics, Inc. | 1994-02-22 |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | 1993-10-18 |
| K922021 | UNICALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | 1990-12-28 |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | 1989-10-06 |
| K893783 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | 1989-06-23 |
| K893784 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | 1989-06-23 |
| K891179 | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 |
| K880712 | CLP NORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | 1988-05-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10859394006061 | PlasmaCon N | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006078 | PlasmaCon L1 | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006085 | PlasmaCon L2 | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 00842768006821 | Berichrom® Heparin UF Control 1 | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006876 | Berichrom® Heparin LMW Control 1 | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00843876000053 | CRYOcheck™ Reference Control Normal | Precision Biologic Inc | 2016-09-23 |
| 00843876000060 | CRYOcheck™ Reference Control Normal | Precision Biologic Inc | 2016-09-23 |
| 00850201006147 | LAtrol NORMAL CONTROL PLASMA | Biomedica ADI Inc. | 2016-09-20 |
| 00845275000559 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 13607450006756 | STA® - Unicalibrator | DIAGNOSTICA STAGO | 2016-09-15 |
| 15391521420777 | TriniCHECK™ D-Dimer 1 | TCOAG IRELAND LIMITED | 2016-09-12 |
| M52553010 | Coagulation S.A.C.-1 (Specialty Assay Control) | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 00855360006243 | REAADS Coagulation Control 1 | CORGENIX MEDICAL CORPORATION | 2016-07-14 |