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 |