The following data is part of a premarket notification filed by Earl-clay Laboratories, Inc. with the FDA for Ultraclone 05-100 Guinea Pig Rbc.
| Device ID | K854206 |
| 510k Number | K854206 |
| Device Name: | ULTRACLONE 05-100 GUINEA PIG RBC |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | EARL-CLAY LABORATORIES, INC. 890 LAMONT AVE. Novato, CA 94947 |
| Contact | Robert E Lovins |
| Correspondent | Robert E Lovins EARL-CLAY LABORATORIES, INC. 890 LAMONT AVE. Novato, CA 94947 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-16 |
| Decision Date | 1985-10-31 |