Vitros Immunodiagnostic Products Range Verifiers
FDA 510(k) K973517 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK973517
Submission
- Device name
- Vitros Immunodiagnostic Products Range Verifiers
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- September 17, 1997
- Decision date
- September 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K980283 | Vitros Chemistry Products CRBM SlidesKLT · Traditional | 02/25/1998SE |
| K974644 | Vitros Immunodiagnostic Products Range VerifiersJJX · Traditional | 01/13/1998SE |
| 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 Immunodiagnostic Products Range Verifiers cleared by the FDA?
Vitros Immunodiagnostic Products Range Verifiers (K973517) received a 510(k) decision of Substantially Equivalent on September 25, 1997, 8 days after the submission was received.
What is the product code of K973517?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.