510(k) DEN990008
- Device
- WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
- Applicant
- Wallac, Inc.
- 510(k) number
- DEN990008
- Product code
- NAK
- Decision
- Unknown (DENG)
- Decision date
- 2000-02-15
- Date received
- 1999-12-20
- Regulation
- 862.1118
- Classification name
- System, Test, Biotinidase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- CARROLL L MARTIN
- Address
- 3985 Eastern Rd. Norton OH US 44203 44203
FDA Registration Numbers#
- 3050015
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | Astoria-Pacific, Inc. | 2001-09-21 |