The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Glucofilm Test Strips.
| Device ID | K936212 |
| 510k Number | K936212 |
| Device Name: | GLUCOFILM TEST 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 | 1993-12-28 |
| Decision Date | 1994-05-10 |