FDA Product Code
FDA Product Code GIZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5425
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K042941 | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | 2004-12-02 | Traditional | PDF ↗ |
| K023309 | CONTROL PLASMA N | Dade Behring, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | 2001-12-10 | Traditional | PDF ↗ |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K001256 | CONTROL PLASMA N | Dade Behring, Inc. | 2000-05-24 | Traditional | PDF ↗ |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | 1998-12-01 | Traditional | PDF ↗ |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Cardiovascular Diagnostics, Inc. | 1996-08-13 | Traditional | PDF ↗ |
| K941737 | SPECIALTY ASSAYED CONTROL-1 | Helena Laboratories | 1994-10-07 | Traditional | PDF ↗ |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | American Diagnostica, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K924403 | CONTROL PLASMA N | Behring Diagnostics, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | 1993-10-18 | Traditional | PDF ↗ |
| K922021 | UNICALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 | Traditional | PDF ↗ |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | 1990-12-28 | Traditional | PDF ↗ |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K893784 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893783 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K891179 | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 | Traditional | PDF ↗ |
| K880712 | CLP NORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | 1988-05-06 | Traditional | PDF ↗ |
Product code GIZ · Class II · Hematology. Data: openFDA.