Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)
FDA 510(k) K964720 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK964720
Submission
- Device name
- Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- November 25, 1996
- Decision date
- February 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K052662 | One Step FSH Menopausal TestCGJ · Traditional | Ind Diagnostic, Inc. | 11/30/2005SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | Phamatech, Inc. | 02/25/2005SE |
| K041165 | FSH Menopause Predictor TestCGJ · Traditional | ACON Laboratories, Inc. | 06/17/2004SE |
| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | Phamatech, Inc. | 05/20/2004SE |
| K030058 | Earlydetect Menopause Test for FSHCGJ · Traditional | Early Detect, Inc. | 07/30/2003SE |
| K002450 | Genua Menopause Monitor Test KitCGJ · Traditional | Genua 1944, Inc. | 01/12/2001SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | Monobind | 09/02/1997SE |
| K970085 | Sealite Sciences Aqualite FSHCGJ · Traditional | Sealite Sciences, Inc. | 02/14/1997SE |
| K964693 | Elecsys FSH AssayCGJ · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
| K962118 | DSL Active FSH IrmaCGJ · Traditional | Diagnostic Systems Laboratories, Inc. | 09/09/1996SE |
More from Diagnostic Systems 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 Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005) cleared by the FDA?
Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005) (K964720) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 71 days after the submission was received.
What is the product code of K964720?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.