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 |