510(k) K080294
- Device
- ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
- Applicant
- ASTORIA-PACIFIC,INC.
- 510(k) number
- K080294
- Product code
- NAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-11-04
- Date received
- 2008-02-04
- Regulation
- 862.1118
- Classification name
- System, Test, Biotinidase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JASON REYNOLDS
- Address
- 15130 SE 82nd Dr. Clackamas OR US 97015 97015
FDA Registration Numbers#
- 3050015
- 8043909
Source Documents#
Other 510(k) Records For Product Code NAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131284 | GSP NEONATAL BIOTINIDASE KIT | Wallac OY | 2013-11-14 |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Perkinelmer, Inc. | 2010-03-05 |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | Astoria-Pacific, Inc. | 2001-09-21 |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | Wallac, Inc. | 2000-02-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary