The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Fujirebio Diagnostics Vitamin D Control.
| Device ID | K110641 |
| 510k Number | K110641 |
| Device Name: | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC 940 CROSSROADS BLVD. Seguin, TX 78155 |
| Contact | John Gormley |
| Correspondent | John Gormley FUJIREBIO DIAGNOSTICS, INC 940 CROSSROADS BLVD. Seguin, TX 78155 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850212007034 | K110641 | 000 |