The following data is part of a premarket notification filed by Interscience, Inc. with the FDA for Red Cell Lysing Reagent 78n 1915-1.
| Device ID | K822324 |
| 510k Number | K822324 |
| Device Name: | RED CELL LYSING REAGENT 78N 1915-1 |
| Classification | Products, Red-cell Lysing Products |
| Applicant | INTERSCIENCE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-03 |
| Decision Date | 1982-11-08 |