The following data is part of a premarket notification filed by Wallac, Inc. with the FDA for Wallac Neonatal Leucine Test Kit Model Nl-1000.
Device ID | K982307 |
510k Number | K982307 |
Device Name: | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 |
Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
Applicant | WALLAC, INC. 3985 EASTERN RD. Norton, OH 44203 |
Contact | Janice K Brownlee |
Correspondent | Janice K Brownlee WALLAC, INC. 3985 EASTERN RD. Norton, OH 44203 |
Product Code | JNB |
CFR Regulation Number | 862.1555 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-01 |
Decision Date | 1999-02-02 |