The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd45, Leucocyte Common Antigen (lca)/fitc And Cd14, Monocyte/rpe.
| Device ID | K964974 |
| 510k Number | K964974 |
| Device Name: | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE |
| Classification | Counter, Differential Cell |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Gretchen M Murray, Ph.d., Rac |
| Correspondent | Gretchen M Murray, Ph.d., Rac 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 | 1996-12-12 |
| Decision Date | 1997-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572028383 | K964974 | 000 |