The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Neonatal Biotinidase Kit, Model 3018.
| Device ID | K090123 |
| 510k Number | K090123 |
| Device Name: | NEONATAL BIOTINIDASE KIT, MODEL 3018 |
| Classification | System, Test, Biotinidase |
| Applicant | PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Product Code | NAK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1118 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147291359 | K090123 | 000 |
| 06438147291342 | K090123 | 000 |