The following data is part of a premarket notification filed by Earl-clay Laboratories, Inc. with the FDA for Ultraxlone Ecl-01-1000 Cell Line.
| Device ID | K843577 |
| 510k Number | K843577 |
| Device Name: | ULTRAXLONE ECL-01-1000 CELL LINE |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | EARL-CLAY LABORATORIES, INC. 7075 REDWOOD BLVD. SUITE F Novato, CA 94947 |
| Contact | Robert E Lovins |
| Correspondent | Robert E Lovins EARL-CLAY LABORATORIES, INC. 7075 REDWOOD BLVD. SUITE F 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 | 1984-09-11 |
| Decision Date | 1984-10-31 |