The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I And Ii.
| Device ID | K952126 |
| 510k Number | K952126 |
| Device Name: | AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1996-02-29 |