The following data is part of a premarket notification filed by React And Co. with the FDA for Hemocue Hemoglobin Calibrator.
| Device ID | K882600 |
| 510k Number | K882600 |
| Device Name: | HEMOCUE HEMOGLOBIN CALIBRATOR |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | REACT AND CO. 1142 MANHATTAN AVE. SUITE 2 Manhattan Beach, CA 90266 |
| Contact | Robert E Adler |
| Correspondent | Robert E Adler REACT AND CO. 1142 MANHATTAN AVE. SUITE 2 Manhattan Beach, CA 90266 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1988-07-18 |