The following data is part of a premarket notification filed by Kvm Technologies, Inc. with the FDA for Kvm Hemoglobin Lysing Reagent.
| Device ID | K883991 |
| 510k Number | K883991 |
| Device Name: | KVM HEMOGLOBIN LYSING REAGENT |
| Classification | Products, Red-cell Lysing Products |
| 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 | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-10-12 |