IRISPEC,CA/CB/CC
FDA 510(k) clearance K072640 · decided 2007-12-21
Clearance details
- K-number
- K072640
- Device name
- IRISPEC,CA/CB/CC
- Applicant
- Iris Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-09-18
- Decision date
- 2007-12-21
- Days to decision
- 94 days
- Clearance type
- Abbreviated
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and recall (Z-0093-2025) | Beckman Coulter, Inc. | 2024-10-16 |
| BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only. recall (Z-0777-2023) | Beckman Coulter, Inc. | 2023-01-03 |