NRBC-CHEX FOR ADVIA
FDA 510(k) clearance K080016 · decided 2008-02-05
Clearance details
- K-number
- K080016
- Device name
- NRBC-CHEX FOR ADVIA
- Applicant
- Streck
- Decision
- Substantially Equivalent
- Date received
- 2008-01-03
- Decision date
- 2008-02-05
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- GJR
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- La Vista, NE, 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 |
|---|---|---|
| NRBC-CHEX FOR LH (K060083) | Streck | 2006-02-09 |
| CELL-CHEX (K000076) | Streck Laboratories, Inc. | 2000-03-03 |
| SEDRATROL (K940430) | Medical Specialties Intl., Inc. | 1995-02-06 |
| RET-CHECK (K900484) | Streck Laboratories, Inc. | 1990-03-09 |
Recalls involving this device
No recalls on record reference this clearance.