Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls
FDA 510(k) K983674 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK983674
Submission
- Device name
- Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- October 20, 1998
- Decision date
- January 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JMM – Column Chromatography & Color Development, Hydroxyproline
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1400
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011052 | Osteomark NTX Point of Care Prescription Home UseJMM · Traditional | Ostex Intl., Inc. | 07/30/2001SE |
| K993706 | Elecsys Serum B-Crosslaps/Serum ImmunoassayJMM · Traditional | Roche Diagnostics Corp. | 07/24/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | Metrika, Inc. | 11/09/1999SE |
| K990843 | Serum Crosslaps One Step ElisaJMM · Traditional | Osteometer Biotech A/S | 07/09/1999SE |
| K983457 | Osteomark NTX Serum EiaJMM · Traditional | Ostex Intl., Inc. | 02/02/1999SE |
| K972788 | Crosslaps ElisaJMM · Traditional | Devices and Diagnostics Consulting Group | 12/22/1998SE |
| K981364 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 08/13/1998SE |
| K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5JMM · Traditional | Diagnostic Products Corp. | 05/01/1998SE |
| K980518 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 03/06/1998SE |
| K974260 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 01/26/1998SE |
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| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
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| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
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| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
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Questions and answers
When was Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls cleared by the FDA?
Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls (K983674) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 101 days after the submission was received.
What is the product code of K983674?
The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.