The following data is part of a premarket notification filed by Bioclinical Laboratory Services, Inc. with the FDA for Lymphocyte Maintenance Medium.
| Device ID | K864396 |
| 510k Number | K864396 |
| Device Name: | LYMPHOCYTE MAINTENANCE MEDIUM |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | BIOCLINICAL LABORATORY SERVICES, INC. 9310 HUNTING VALLEY RD. Clarence, NY 14031 |
| Contact | Richard Fike |
| Correspondent | Richard Fike BIOCLINICAL LABORATORY SERVICES, INC. 9310 HUNTING VALLEY RD. Clarence, NY 14031 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-06 |
| Decision Date | 1987-02-02 |