Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone Calibrators (GEM.C070)
FDA 510(k) K972133 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK972133
Submission
- Device name
- Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone Calibrators (GEM.C070)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- June 6, 1997
- Decision date
- June 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JLS – Radioimmunoassay, Progesterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1620
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | Ibl GmbH | 07/22/2004SE |
| K973898 | Progesterone ElisaJLS · Traditional | Kmi Diagnostics, Inc. | 11/13/1997SE |
| K971725 | Opus ProgesteroneJLS · Traditional | Behring Diagnostics, Inc. | 06/18/1997SE |
| K964841 | Elecsys Progesterone AssayJLS · Traditional | Boehringer Mannheim Corp. | 03/24/1997SE |
| K965084 | Vidas Proesterone (PRG) (30 409)JLS · Traditional | bioMerieux, Inc. | 01/09/1997SE |
| K955025 | Axsym ProgesteroneJLS · Traditional | Abbott Laboratories | 03/07/1996SE |
| K955769 | Access Progesterone AssayJLS · Traditional | Bio-Rad Laboratories, Inc. | 02/05/1996SE |
| K952075 | Progesterone Assay for the Technicon Immuno 1 System In-Bitro Diagnostic SystemJLS · Traditional | Bayer Corp. | 06/13/1995SE |
| K951630 | Auraflex Progesterone 150TEST PackJLS · Traditional | Organon Teknika Corp. | 05/08/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | Baxter Diagnostics, Inc. | 04/11/1995SE |
More from Baxter Diagnostics, 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 |
| 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 Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone Calibrators (GEM.C070) cleared by the FDA?
Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone Calibrators (GEM.C070) (K972133) received a 510(k) decision of Substantially Equivalent on June 24, 1997, 18 days after the submission was received.
What is the product code of K972133?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.