K003112 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 2, 2000, 29 days after receiving the submission on October 4, 2000.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K003112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2000 |
| Decision Date | November 02, 2000 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |