The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Anti-hav Total Reagent Pack,calibrator,controls.
Device ID | K060678 |
510k Number | K060678 |
Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS |
Classification | Hepatitis A Test (antibody And Igm Antibody) |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Sarah Parsons |
Correspondent | Sarah Parsons Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | LOL |
CFR Regulation Number | 866.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-14 |
Decision Date | 2006-09-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750001293 | K060678 | 000 |