The following data is part of a premarket notification filed by Standard Diagnostics, Inc. with the FDA for Sd Check Gold.
| Device ID | K082683 |
| 510k Number | K082683 |
| Device Name: | SD CHECK GOLD |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | STANDARD DIAGNOSTICS, INC. 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose STANDARD DIAGNOSTICS, INC. 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2009-12-08 |
| Summary: | summary |