The following data is part of a premarket notification filed by Larken Industries, Inc. with the FDA for Glucochek S.c. With Audio Option.
| Device ID | K871586 |
| 510k Number | K871586 |
| Device Name: | GLUCOCHEK S.C. WITH AUDIO OPTION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LARKEN INDUSTRIES, INC. 8275 MELROSE Lenexa, KS 66214 |
| Contact | Daniel Boone |
| Correspondent | Daniel Boone LARKEN INDUSTRIES, INC. 8275 MELROSE Lenexa, KS 66214 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-23 |
| Decision Date | 1987-09-16 |