Fiagen HFSH Time-Resolved Fluoroimmunoassay Kit
FDA 510(k) K884708 · Cyberfluor, Inc.
510(k) numberK884708
Submission
- Device name
- Fiagen HFSH Time-Resolved Fluoroimmunoassay Kit
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- November 9, 1988
- Decision date
- January 17, 1989
- 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
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| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | Phamatech, Inc. | 05/20/2004SE |
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| 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 |
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| K923410 | Fiagen ProgesteroneJLS · Traditional | 12/03/1992SE |
| K905656 | Flagen Triiodothyronine (T3) AssayCDP · Traditional | 01/23/1991SE |
| K904539 | Flagen TM Free T4CEC · Traditional | 11/30/1990SE |
| K900621 | Fiagen(Tm) Hlh.SCEP · Traditional | 03/01/1990SE |
| K895186 | Fiagen T3 Uptake Catalogue #101-402KHQ · Traditional | 11/08/1989SE |
| K895396 | Cyberfluor Fiagen TSHJLW · Traditional | 10/31/1989SE |
| K884707 | Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional | 01/17/1989SE |
| K884201 | Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional | 12/14/1988SE |
| K883182 | Fiagen Rubella IggLFX · Traditional | 10/31/1988SE |
| K882823 | Fiagen HGH Fluoroimmunoassay KitCFL · Traditional | 08/30/1988SE |
Questions and answers
When was Fiagen HFSH Time-Resolved Fluoroimmunoassay Kit cleared by the FDA?
Fiagen HFSH Time-Resolved Fluoroimmunoassay Kit (K884708) received a 510(k) decision of Substantially Equivalent on January 17, 1989, 69 days after the submission was received.
What is the product code of K884708?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.