The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Ultra+ Blood Glucose Monitoring Test Strip.
| Device ID | K922136 |
| 510k Number | K922136 |
| Device Name: | ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HOME DIAGNOSTICS, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Maureen Garner |
| Correspondent | Maureen Garner HOME DIAGNOSTICS, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-22 |
| Decision Date | 1993-08-10 |