The following data is part of a premarket notification filed by Kdk Corp. with the FDA for Lactate Pro System.
| Device ID | K980908 |
| 510k Number | K980908 |
| Device Name: | LACTATE PRO SYSTEM |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | KDK CORP. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU Kyoto, JP 601 |
| Contact | Kazuo Iketaki |
| Correspondent | Kazuo Iketaki KDK CORP. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU Kyoto, JP 601 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-10 |
| Decision Date | 1998-09-11 |
| Summary: | summary |