The following data is part of a premarket notification filed by Biotek Solutions, Inc. with the FDA for Chemmate(tm) Uchl1 (cd45-ro).
| Device ID | K950152 |
| 510k Number | K950152 |
| Device Name: | CHEMMATE(TM) UCHL1 (CD45-RO) |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | BIOTEK SOLUTIONS, INC. 120-B CREMONA DR. Santa Barbara, CA 93117 |
| Contact | Debotah D Hinman |
| Correspondent | Debotah D Hinman BIOTEK SOLUTIONS, INC. 120-B CREMONA DR. Santa Barbara, CA 93117 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-10-27 |