Vitros Immunodiagnostic System
FDA 510(k) K962919 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK962919
Submission
- Device name
- Vitros Immunodiagnostic System
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- July 26, 1996
- Decision date
- October 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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| K935047 | Auto DelfiaKHO · Traditional | Wallac OY | 05/23/1994SE |
| K930689 | Autobead Thyroid UptakeKHO · Traditional | Bio-Chem Laboratory Systems, Inc. | 11/10/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | Pb Diagnostic Systems, Inc. | 06/07/1993SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Corp. | 07/21/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | Dynatech Laboratories, Inc. | 03/19/1992SE |
More from Dynatech Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980283 | Vitros Chemistry Products CRBM SlidesKLT · Traditional | 02/25/1998SE |
| K974644 | Vitros Immunodiagnostic Products Range VerifiersJJX · Traditional | 01/13/1998SE |
| K973517 | Vitros Immunodiagnostic Products Range VerifiersJJY · Traditional | 09/25/1997SE |
| K973030 | Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators…JJY · Traditional | 09/04/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | 06/24/1997SE |
| K970894 | Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (GEM.1075), Total B-Hcg…DHA · Traditional | 04/14/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | 03/18/1997SE |
| K965142 | Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators…CEC · Traditional | 03/18/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | 02/25/1997SE |
| K964982 | Vitros Immunodiagnostics Products LH Reagent Pack (GEM.1055) and LH Calibrators (GEM.CO55)CEP · Traditional | 02/20/1997SE |
Questions and answers
When was Vitros Immunodiagnostic System cleared by the FDA?
Vitros Immunodiagnostic System (K962919) received a 510(k) decision of Substantially Equivalent on October 18, 1996, 84 days after the submission was received.
What is the product code of K962919?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.