The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Cd3 Fitc/cd19 R-pe/cd45 Tri-color Monoclonal Antibody Combination.
| Device ID | K964856 |
| 510k Number | K964856 |
| Device Name: | CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION |
| Classification | Counter, Differential Cell |
| Applicant | CALTAG LABORATORIES, INC. 605 DILWORTH RD. Downingtown, PA 19335 |
| Contact | David C Bishop, Ph.d. |
| Correspondent | David C Bishop, Ph.d. CALTAG LABORATORIES, INC. 605 DILWORTH RD. Downingtown, PA 19335 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-04 |
| Decision Date | 1997-01-17 |
| Summary: | summary |