The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison 25 Oh Vitamin D Total Calibration Verifiers, Model: 310603.
Device ID | K090104 |
510k Number | K090104 |
Device Name: | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Contact | Kelly R Sauer |
Correspondent | Kelly R Sauer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-01-15 |
Decision Date | 2009-09-09 |
Summary: | summary |