Submission Details
| 510(k) Number | K041322 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 18, 2004 |
| Decision Date | June 17, 2004 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Special
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
Jun 2004
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K041322 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 17, 2004, 30 days after receiving the submission on May 18, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.
Device Classification
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
Manufacturer
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