The following data is part of a premarket notification filed by Rjo Biologicals, Inc. with the FDA for Mlc Normal Serum.
| Device ID | K870580 |
| 510k Number | K870580 |
| Device Name: | MLC NORMAL SERUM |
| Classification | Sera, Animal And Human |
| Applicant | RJO BIOLOGICALS, INC. 6038 TROOST AVE. Kansas City, MO 64110 |
| Contact | David M Charnecki |
| Correspondent | David M Charnecki RJO BIOLOGICALS, INC. 6038 TROOST AVE. Kansas City, MO 64110 |
| Product Code | KIS |
| CFR Regulation Number | 864.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-11 |
| Decision Date | 1987-04-08 |