TRU-TRAX
FDA 510(k) clearance K894851 · decided 1989-09-29
Clearance details
- K-number
- K894851
- Device name
- TRU-TRAX
- Applicant
- Humagen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-31
- Decision date
- 1989-09-29
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- GIO
- Device class
- 1
- Regulation number
- 864.6150
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Charlottesville, VA, 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 |
|---|---|---|
| QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (K972969) | Innovative Medical Technologies, Inc. | 1997-09-22 |
| MONOJECT SAMPLETTE SEPARATOR TUBE (K941291) | Sherwood Medical Co. | 1994-10-27 |
| HEMA(PRO)TEC(TION) (K885324) | Medical Products Search, Inc. | 1989-02-17 |
| CAPILLARY TUBE, BLOOD COLLECTION (K885138) | Coeur Laboratories, Inc. | 1989-02-07 |
| SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (K884623) | Safe-Tec Clinical Products, Inc. | 1988-12-01 |
| NATELSON TUBES, HEPARIN AND PLAIN (K881187) | Helps Products, Inc. | 1988-05-06 |
| CARAWAY TUBES, HEPARIN AND PLAIN (K881262) | Helps Products, Inc. | 1988-05-06 |
| MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (K875061) | Sherwood Medical Co. | 1988-01-12 |
| VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (K873647) | Ventrex Laboratories, Inc. | 1987-10-20 |
| CORNING BLOOD COLLECTION CAPILLARY TUBES (K850806) | Corning Medical & Scientific | 1985-03-25 |
| CAPILLARY BLOOD COLLECTION TUBE (K843608) | Medical Technomics, Ltd. | 1984-11-30 |
| MICRO HEMATOCRIT CAPILLARY TUBES (K843892) | Abco Dealers, Inc. | 1984-11-13 |
Recalls involving this device
No recalls on record reference this clearance.