The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic System.
| Device ID | K962919 |
| 510k Number | K962919 |
| Device Name: | VITROS IMMUNODIAGNOSTIC SYSTEM |
| Classification | Fluorometer, For Clinical Use |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Charles C Morganson, Jr. |
| Correspondent | Charles C Morganson, Jr. JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-26 |
| Decision Date | 1996-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750011308 | K962919 | 000 |
| 10758750001040 | K962919 | 000 |
| 10758750000272 | K962919 | 000 |