The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Glucostix Reagent Strips.
Device ID | K926362 |
510k Number | K926362 |
Device Name: | GLUCOSTIX REAGENT STRIPS |
Classification | Glucose Oxidase, Glucose |
Applicant | HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
Contact | Rosanne M Savol |
Correspondent | Rosanne M Savol HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-21 |
Decision Date | 1993-11-10 |