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 |