The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products Fs Calibrator 1, Ref 6801873;.
| Device ID | K052645 |
| 510k Number | K052645 |
| Device Name: | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Michael M Byrne |
| Correspondent | Michael M Byrne ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2005-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750002733 | K052645 | 000 |
| 10758750002726 | K052645 | 000 |