The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Lancer Glucose Rate Reagent Kit.
| Device ID | K801071 |
| 510k Number | K801071 |
| Device Name: | LANCER GLUCOSE RATE REAGENT KIT |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-05-23 |