IRI SPEC URINALYSIS CONTROL
FDA 510(k) clearance K832713 · decided 1983-12-22
Clearance details
- K-number
- K832713
- Device name
- IRI SPEC URINALYSIS CONTROL
- Applicant
- Intl. Remote Imaging Systems
- Decision
- Substantially Equivalent
- Date received
- 1983-08-12
- Decision date
- 1983-12-22
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intl. Remote Imaging Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. P recall (Z-1328-2013) | Iris Diagnostics | 2013-05-15 |