The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue Glucose 201 System, Article Number 120706.
| Device ID | K020935 |
| 510k Number | K020935 |
| Device Name: | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HEMOCUE, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | R.j. Slomoff |
| Correspondent | R.j. Slomoff HEMOCUE, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-22 |
| Decision Date | 2002-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091207074 | K020935 | 000 |
| 07311091207067 | K020935 | 000 |
| 07311091107237 | K020935 | 000 |
| 07311091107060 | K020935 | 000 |
| 07311091107053 | K020935 | 000 |