K030067 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS. This device is classified as a Kit, Serological, Positive Control (Class I - General Controls, product code MJX).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on January 17, 2003, 10 days after receiving the submission on January 7, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K030067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2003 |
| Decision Date | January 17, 2003 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MJX — Kit, Serological, Positive Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |