The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Cd3 Tri-color/cd4 R-pe/cd8 Fitc Monoclonal Antibody Combination.
| Device ID | K951073 |
| 510k Number | K951073 |
| Device Name: | CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION |
| Classification | Counter, Differential Cell |
| Applicant | CALTAG LABORATORIES, INC. 436 ROZZI PLACE South San Francisco, CA 94080 |
| Contact | Tony Lam |
| Correspondent | Tony Lam CALTAG LABORATORIES, INC. 436 ROZZI PLACE South San Francisco, CA 94080 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-08 |
| Decision Date | 1995-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190302005265 | K951073 | 000 |