The following data is part of a premarket notification filed by Larken Industries, Inc. with the FDA for Glucochek Iii.
| Device ID | K842474 |
| 510k Number | K842474 |
| Device Name: | GLUCOCHEK III |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | LARKEN INDUSTRIES, INC. 8347 MELROSE Lenexa , KS 66214 - |
| Contact | Ken Anderson |
| Correspondent | Ken Anderson LARKEN INDUSTRIES, INC. 8347 MELROSE Lenexa , KS 66214 - |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-25 |
| Decision Date | 1985-02-12 |