The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Glucose Testcard Use W/ilex Prompt Clinical Ch Ana.
| Device ID | K864282 |
| 510k Number | K864282 |
| Device Name: | GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | William Morton |
| Correspondent | William Morton MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-30 |
| Decision Date | 1987-05-26 |