The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Aalto Ldh Isoenzyme Control Serum.
| Device ID | K820360 |
| 510k Number | K820360 |
| Device Name: | AALTO LDH ISOENZYME CONTROL SERUM |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | AALTO SCIENTIFIC LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-03-04 |