The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv Tumor Markers Linearity Set, Model K719m-5.
Device ID | K082717 |
510k Number | K082717 |
Device Name: | AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
Contact | Brandon J Perez |
Correspondent | Brandon J Perez AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-17 |
Decision Date | 2008-10-30 |
Summary: | summary |