The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Ca15-3 Range Verifiers, Ca125 Ii Range Verifiers, Psa Range Verifiers.
| Device ID | K990783 |
| 510k Number | K990783 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Anne Zavertnik |
| Correspondent | Anne Zavertnik Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-09 |
| Decision Date | 1999-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750001002 | K990783 | 000 |
| 10758750000999 | K990783 | 000 |