The following data is part of a premarket notification filed by Kvm Technologies, Inc. with the FDA for Kvm Prepack Hematology Reagent Set.
| Device ID | K883992 |
| 510k Number | K883992 |
| Device Name: | KVM PREPACK HEMATOLOGY REAGENT SET |
| Classification | Cyanomethemoglobin |
| Applicant | KVM TECHNOLOGIES, INC. 9431 ROARK RD. Houston, TX 77099 |
| Contact | Moossy, Jr |
| Correspondent | Moossy, Jr KVM TECHNOLOGIES, INC. 9431 ROARK RD. Houston, TX 77099 |
| Product Code | GKK |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-10-12 |