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 |