The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Rhesus Monkey Blood In Alsever's.
| Device ID | K813512 |
| 510k Number | K813512 |
| Device Name: | RHESUS MONKEY BLOOD IN ALSEVER'S |
| Classification | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment |
| Applicant | DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHW |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-15 |
| Decision Date | 1981-12-29 |