The following data is part of a premarket notification filed by Reagent Laboratory, Inc. with the FDA for Hemolyse.
| Device ID | K863503 |
| 510k Number | K863503 |
| Device Name: | HEMOLYSE |
| Classification | Products, Red-cell Lysing Products |
| Applicant | REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Contact | Donald Skaggs |
| Correspondent | Donald Skaggs REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-10-03 |