The following data is part of a premarket notification filed by Dako Corp. with the FDA for Rabbit Antiserum To Human Kappa Light.
| Device ID | K831904 |
| 510k Number | K831904 |
| Device Name: | RABBIT ANTISERUM TO HUMAN KAPPA LIGHT |
| Classification | Kappa, Fitc, Antigen, Antiserum, Control |
| Applicant | DAKO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DEO |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-14 |
| Decision Date | 1983-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572002444 | K831904 | 000 |