The following data is part of a premarket notification filed by Jwt, Inc. with the FDA for Lactest I.
| Device ID | K971944 |
| 510k Number | K971944 |
| Device Name: | LACTEST I |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | JWT, INC. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Contact | James B Johnston |
| Correspondent | James B Johnston JWT, INC. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-12-17 |