IRISPEC URINE CHEMISTRY CONTROL PART A AND B
FDA 510(k) clearance K945913 · decided 1995-04-05
Clearance details
- K-number
- K945913
- Device name
- IRISPEC URINE CHEMISTRY CONTROL PART A AND B
- Applicant
- International Remote Imaging Systems
- Decision
- Substantially Equivalent
- Date received
- 1994-12-02
- Decision date
- 1995-04-05
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chartsworth, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch International 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 |
|---|---|---|
| IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800 recall (Z-2124-2012) | Iris Diagnostics | 2012-08-01 |
| IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. recall (Z-0884-05) | International Remote Imaging Systems Inc | 2005-06-11 |