The following data is part of a premarket notification filed by Biotek Solutions, Inc. with the FDA for Chemmate Special Stain Lca-cd45.
| Device ID | K936111 |
| 510k Number | K936111 |
| Device Name: | CHEMMATE SPECIAL STAIN LCA-CD45 |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | BIOTEK SOLUTIONS, INC. 120 B CREMONA DR. Santa Barbara, CA 93117 |
| Contact | Elliott Friedman |
| Correspondent | Elliott Friedman BIOTEK SOLUTIONS, INC. 120 B CREMONA DR. Santa Barbara, CA 93117 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1996-02-27 |