The following data is part of a premarket notification filed by In Vitro Diagnostics, Inc. with the FDA for Reagents For Use On Contraves Dc300, Dc500, Al801.
| Device ID | K873832 |
| 510k Number | K873832 |
| Device Name: | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | IN VITRO DIAGNOSTICS, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Contact | Jay Mininberg |
| Correspondent | Jay Mininberg IN VITRO DIAGNOSTICS, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-21 |
| Decision Date | 1987-11-23 |