The following data is part of a premarket notification filed by Dako Corp. with the FDA for Monoclonal Mouse Anti-human T-cell, Cd4, Clone Mt310, Fitc-conjugated, (anti-cd4/fitc, Mt310) Rpe-conjugated, (anti-cd4/.
| Device ID | K945212 |
| 510k Number | K945212 |
| Device Name: | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ |
| Classification | Counter, Differential Cell |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Gretchen Murray |
| Correspondent | Gretchen Murray DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1996-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572028444 | K945212 | 000 |
| 05700572028369 | K945212 | 000 |