The following data is part of a premarket notification filed by Toa Medical Electronics Usa, Inc. with the FDA for Sysmex Hematological Whole Blood Diluting Reagent-.
| Device ID | K850239 |
| 510k Number | K850239 |
| Device Name: | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- |
| Classification | Diluent, Blood Cell |
| Applicant | TOA MEDICAL ELECTRONICS USA, INC. 1515 E DEL AMO BLVD. Carson, CA 90746 |
| Contact | Michael L Kohut |
| Correspondent | Michael L Kohut TOA MEDICAL ELECTRONICS USA, INC. 1515 E DEL AMO BLVD. Carson, CA 90746 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-04-01 |