URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
FDA 510(k) clearance K970277 · decided 1997-12-11
Clearance details
- K-number
- K970277
- Device name
- URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
- Applicant
- Astoria-Pacific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-23
- Decision date
- 1997-12-11
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- KQP
- Device class
- 2
- Regulation number
- 862.1315
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clackamas, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-acc recall (Z-1659-2015) | Siemens Medical Solutions Diagnostics | 2015-05-23 |