The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Caltag Cd4 R-pe Monoclonal Antibody.
| Device ID | K944128 |
| 510k Number | K944128 |
| Device Name: | CALTAG CD4 R-PE MONOCLONAL ANTIBODY |
| 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 | 1994-08-23 |
| Decision Date | 1995-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190302005425 | K944128 | 000 |
| 10190302005418 | K944128 | 000 |