510(k) K010844
- Device
- ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
- Applicant
- ASTORIA-PACIFIC,INC.
- 510(k) number
- K010844
- Product code
- NAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-21
- Date received
- 2001-03-21
- 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
- RAYMOND L PAVITT
- Address
- 15130 SE 82nd Dr. P.O. Box 830 Clakamas 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 |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2008-11-04 |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | Wallac, Inc. | 2000-02-15 |
Legacy Summary#
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FDA Review#
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