GSP NEONATAL BIOTINIDASE KIT
FDA 510(k) clearance K131284 · decided 2013-11-14
Clearance details
- K-number
- K131284
- Device name
- GSP NEONATAL BIOTINIDASE KIT
- Applicant
- Wallac OY
- Decision
- Substantially Equivalent
- Date received
- 2013-05-06
- Decision date
- 2013-11-14
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- NAK
- Device class
- 2
- Regulation number
- 862.1118
- 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 |
|---|---|---|
| NEONATAL BIOTINIDASE KIT, MODEL 3018 (K090123) | Perkinelmer, Inc. | 2010-03-05 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (K080294) | Astoria-Pacific, Inc. | 2008-11-04 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (K010844) | Astoria-Pacific, Inc. | 2001-09-21 |
| WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 (DEN990008) | Wallac, Inc. | 2000-02-15 |
Recalls involving this device
No recalls on record reference this clearance.