The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Criterion, Hemocue B-hemoglobin Control.
| Device ID | K921681 |
| 510k Number | K921681 |
| Device Name: | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL |
| Classification | Control, Hemoglobin |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Janet D Perkins |
| Correspondent | Janet D Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-11-17 |