The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Monoclonal Antibody Anti-cd2.
| Device ID | K901187 |
| 510k Number | K901187 |
| Device Name: | MONOCLONAL ANTIBODY ANTI-CD2 |
| Classification | Counter, Differential Cell |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Takes, Phd |
| Correspondent | Takes, Phd SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1991-10-31 |