Follicle Stimulating Hormone (HFSH)
FDA 510(k) K871317 · Immuchem Corp.
510(k) numberK871317
Submission
- Device name
- Follicle Stimulating Hormone (HFSH)
- Applicant
- Immuchem Corp.
Carson, CA, US - Received
- April 2, 1987
- Decision date
- May 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K964720 | Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)CGJ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/04/1997SE |
| K964693 | Elecsys FSH AssayCGJ · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K883726 | Thyroid Stimulating Hormone (HTSH) Irma NeonatalJLW · Traditional | 12/15/1988SE |
| K871542 | Hprolactin KitCFT · Traditional | 05/14/1987SE |
| K865071 | Thyroid Stimulating Hormone (TSH Irma) Ria KitJLW · Traditional | 03/13/1987SE |
| K864144 | Luteinizing Hormone (Lh-Irma) Ria KitCEP · Traditional | 11/24/1986SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | 03/14/1986SE |
| K854094 | Immuchem Covalent Coat a Solid Phase RadioimmunoasJLS · Traditional | 02/28/1986SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | 05/04/1983SE |
| K822509 | Covalent Coat Ria KitCFP · Traditional | 09/28/1982SE |
| K822140 | Immuchem Covalent-CoatJKC · Traditional | 08/05/1982SE |
| K820329 | Estradiol Kit by RiaCHP · Traditional | 03/04/1982SE |
Questions and answers
When was Follicle Stimulating Hormone (HFSH) cleared by the FDA?
Follicle Stimulating Hormone (HFSH) (K871317) received a 510(k) decision of Substantially Equivalent on May 20, 1987, 48 days after the submission was received.
What is the product code of K871317?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.