COULTER POSITIVE CONTROL CELLS
FDA 510(k) clearance K894651 · decided 1989-09-13
Clearance details
- K-number
- K894651
- Device name
- COULTER POSITIVE CONTROL CELLS
- Applicant
- Coulter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-24
- Decision date
- 1989-09-13
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- GGL
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hialeah, FL, 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 |
|---|---|---|
| CD4 COUNT (K083926) | Streck | 2009-02-11 |
| CD-CHEX PLUS BC (K051633) | Streck | 2005-08-16 |
| CD-CHEX CD 34 (K993126) | Streck Laboratories, Inc. | 1999-11-26 |
| CD-CHEX + RBC (K960894) | Streck Laboratories, Inc. | 1996-05-24 |
| CD-CHEX CD4 LOW (K931825) | Streck Laboratories, Inc. | 1994-06-06 |
| CD-CHEX (K920997) | Streck Laboratories, Inc. | 1992-05-31 |
| EDL ABNORMAL COAGULATION CONTROL (K891175) | Elite Diagnostic , Ltd. | 1989-04-10 |
Recalls involving this device
No recalls on record reference this clearance.