The following data is part of a premarket notification filed by Earl-clay Laboratories, Inc. with the FDA for Ultraclone 01-2300 Cell Line.
| Device ID | K861585 |
| 510k Number | K861585 |
| Device Name: | ULTRACLONE 01-2300 CELL LINE |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | EARL-CLAY LABORATORIES, INC. 890 LAMONT AVE. Novato, CA 94947 |
| Contact | Steven A Evans |
| Correspondent | Steven A Evans EARL-CLAY LABORATORIES, INC. 890 LAMONT AVE. Novato, CA 94947 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-05-13 |