The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Calibrators.
Device ID | K013899 |
510k Number | K013899 |
Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS |
Classification | Radioassay, Vitamin B12 |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Marlene A Shulman |
Correspondent | Marlene A Shulman ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | CDD |
CFR Regulation Number | 862.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-23 |
Decision Date | 2002-01-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750009367 | K013899 | 000 |
10758750009138 | K013899 | 000 |
10758750008476 | K013899 | 000 |