The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Aalto Scientific Ltd. Glycated Hemoglobin Control Levels I & Ii.
| Device ID | K952720 |
| 510k Number | K952720 |
| Device Name: | AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II |
| Classification | Mixture, Hematology Quality Control |
| 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 | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1995-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014566 | K952720 | 000 |