Vitros Chemistry Products CRBM Slides
FDA 510(k) K980283 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK980283
Submission
- Device name
- Vitros Chemistry Products CRBM Slides
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- January 26, 1998
- Decision date
- February 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KLT – Enzyme Immunoassay, Carbamazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151578 | Carbamazepine Gen 4KLT · Traditional | Roche Diagnostics Operations (Rdo) | 10/22/2015SE |
| K123518 | Abbott Carbamazepine AssayKLT · Traditional | Microgenics Corporation | 06/05/2013SE |
| K103627 | Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine CalibratorsKLT · Traditional | Abbott Laboratories | 10/14/2011SE |
| K063131 | Carbamazepine, Valproic Acid, TDM Calibration Set B and Abtrol, Nortrol ControlsKLT · Traditional | Thermo Electron OY | 10/05/2007SE |
| K042808 | Advia Ims Carbamazepine MethodKLT · Traditional | Bayer Healthcare, LLC | 02/08/2005SE |
| K031902 | Online TDM CarbamazepineKLT · Traditional | Roche Diagnostics Corp. | 09/17/2003SE |
| K011648 | Randox CarbamazepineKLT · Traditional | Randox Laboratories, Ltd. | 01/15/2002SE |
| K010814 | Emit 2000 Carbamazepine Assay, Model OSR4F229KLT · Special | Syva Co., Dade Behring, Inc. | 04/13/2001SE |
| K000903 | Additional Assays for Bayer Advia Ims SystemKLT · Traditional | Bayer Corp. | 05/18/2000SE |
| K000007 | Immulite Carbamazepine, Immulite 2000 Carbamazepine, Catalog # LKCB1, LKCB5 & L2KCB2…KLT · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K964960 | Vitros Chemistry Products Upro SlidesJGP · Traditional | 02/18/1997SE |
Questions and answers
When was Vitros Chemistry Products CRBM Slides cleared by the FDA?
Vitros Chemistry Products CRBM Slides (K980283) received a 510(k) decision of Substantially Equivalent on February 25, 1998, 30 days after the submission was received.
What is the product code of K980283?
The FDA product code is KLT – Enzyme Immunoassay, Carbamazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3645.