ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
FDA 510(k) clearance K080294 · decided 2008-11-04
Clearance details
- K-number
- K080294
- Device name
- ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
- Applicant
- Astoria-Pacific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-04
- Decision date
- 2008-11-04
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- NAK
- Device class
- 2
- Regulation number
- 862.1118
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clackamas, OR, 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 BIOTINIDASE KIT (K131284) | Wallac OY | 2013-11-14 |
| NEONATAL BIOTINIDASE KIT, MODEL 3018 (K090123) | Perkinelmer, Inc. | 2010-03-05 |
| 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.