The following data is part of a premarket notification filed by Direct Solutions with the FDA for Hemocue Glucolin.
| Device ID | K963909 |
| 510k Number | K963909 |
| Device Name: | HEMOCUE GLUCOLIN |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 Westford, MA 01886 |
| Contact | Bill Donohue |
| Correspondent | Bill Donohue DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 Westford, MA 01886 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1996-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718734961406 | K963909 | 000 |