Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators
FDA 510(k) K994145 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK994145
Submission
- Device name
- Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- December 8, 1999
- Decision date
- December 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122126 | Direct Ldl/Hdl Cholesterol CalibratorJIS · Traditional | Randox Laboratories Limited | 08/14/2012SE |
| K061251 | Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional | Dade Behring, Inc. | 05/31/2006SE |
| K060266 | Dimension Iron CalibratorJIS · Traditional | Dade Behring, Inc. | 03/09/2006SE |
| K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional | Dade Behring, Inc. | 12/23/2005SE |
| K032697 | Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional | Dade Behring, Inc. | 11/07/2003SE |
| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
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Questions and answers
When was Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators cleared by the FDA?
Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators (K994145) received a 510(k) decision of Substantially Equivalent on December 22, 1999, 14 days after the submission was received.
What is the product code of K994145?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.