STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
FDA 510(k) clearance K060968 · decided 2007-05-15
Clearance details
- K-number
- K060968
- Device name
- STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
- Applicant
- Wortham Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-07
- Decision date
- 2007-05-15
- Days to decision
- 403 days
- Clearance type
- Traditional
- Product code
- GIZ
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chattanooga, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (K042941) | Dade Behring, Inc. | 2004-12-02 |
| CONTROL PLASMA N (K023309) | Dade Behring, Inc. | 2002-11-01 |
| REFERENCE CHECK, CATALOG NUMBER-RCN-10 (K013708) | Precision Biologic | 2001-12-10 |
| ACCUCLOT CONTROL I, MODEL A4089 (K003328) | Sigma Diagnostics, Inc. | 2001-03-01 |
| CONTROL PLASMA N (K001256) | Dade Behring, Inc. | 2000-05-24 |
| COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129) | Pacific Hemostasis | 1998-12-01 |
| ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274) | Sigma Diagnostics, Inc. | 1997-10-31 |
| THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (K961814) | Cardiovascular Diagnostics, Inc. | 1996-08-13 |
| SPECIALTY ASSAYED CONTROL-1 (K941737) | Helena Laboratories | 1994-10-07 |
| DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (K935254) | American Diagnostica, Inc. | 1994-09-19 |
| CONTROL PLASMA N (K924403) | Behring Diagnostics, Inc. | 1994-02-22 |
| COAGULATION REFERENCE PLASMA, NORMAL (K932145) | American Diagnostic Corp. | 1993-10-18 |
Recalls involving this device
No recalls on record reference this clearance.