The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Complete D 25-oh Vitamin D Control.
Device ID | K113177 |
510k Number | K113177 |
Device Name: | COMPLETE D 25-OH VITAMIN D CONTROL |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
Contact | Kalyna Snylyk |
Correspondent | Kalyna Snylyk QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-28 |
Decision Date | 2012-05-10 |
Summary: | summary |