AUTODELFIA NEONATAL IRT KIT
FDA 510(k) clearance K110274 · decided 2011-06-10
Clearance details
- K-number
- K110274
- Device name
- AUTODELFIA NEONATAL IRT KIT
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-31
- Decision date
- 2011-06-10
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- JNO
- Device class
- 1
- Regulation number
- 862.1725
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Waltham, MA, 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 |
|---|---|---|
| GSP NEONATAL IRT KIT (3306-001U) (K102419) | Wallac Oy, Subsidiary of Perkinelmer | 2010-12-16 |
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| TRYPIN (125I) RIA KIT (K811805) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-31 |
| RIA KIT FOR TRYPSIN (K791202) | Cis Radiopharmaceuticals, Inc. | 1979-11-05 |
Recalls involving this device
No recalls on record reference this clearance.