The following data is part of a premarket notification filed by Biotek Solutions, Inc. with the FDA for Chemmate(tm) Cd43.
| Device ID | K950148 |
| 510k Number | K950148 |
| Device Name: | CHEMMATE(TM) CD43 |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | BIOTEK SOLUTIONS, INC. 120-B CREMONA DR. Santa Barbara, CA 93117 |
| Contact | Deborah D Hinman |
| Correspondent | Deborah D Hinman 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 | 1995-01-17 |
| Decision Date | 1996-07-02 |
| Summary: | summary |