The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Wako B.g. Pretest Strips.
| Device ID | K842207 |
| 510k Number | K842207 |
| Device Name: | WAKO B.G. PRETEST STRIPS |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HEALTHDYNE, INC. 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 | 1984-06-04 |
| Decision Date | 1984-06-26 |