The following data is part of a premarket notification filed by Hematology Marketing Assoc. with the FDA for Laser-lyse.
| Device ID | K850097 |
| 510k Number | K850097 |
| Device Name: | LASER-LYSE |
| Classification | Products, Red-cell Lysing Products |
| Applicant | HEMATOLOGY MARKETING ASSOC. P.O. BOX 6756 Concord, CA 94524 |
| Contact | James Lapicola |
| Correspondent | James Lapicola HEMATOLOGY MARKETING ASSOC. P.O. BOX 6756 Concord, CA 94524 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-11 |
| Decision Date | 1985-03-29 |