The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Aalto Scientific Sweat Chloride Reference Material.
| Device ID | K951435 |
| 510k Number | K951435 |
| Device Name: | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1160 JOSHUA WAY Vista, CA 92083 -7836 |
| Contact | Kevin Jones |
| Correspondent | Kevin Jones AALTO SCIENTIFIC LTD. 1160 JOSHUA WAY Vista, CA 92083 -7836 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-05-02 |