The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Clinical Laboratory Analyzing System.
| Device ID | K041230 |
| 510k Number | K041230 |
| Device Name: | CLINICAL LABORATORY ANALYZING SYSTEM |
| Classification | Glucose Dehydrogenase, 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 | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091214447 | K041230 | 000 |
| 07311091214225 | K041230 | 000 |