Panels › Clinical Chemistry › Product code CGJ · Class 1
Radioimmunoassay, Follicle-Stimulating Hormone
Regulation 862.1300
0510(k)s in 12 months (88 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in CGJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 Open, Classified |
CGJ | K052662 |
| Mar 25, 2022 | Ortho-Clinical Diagnostics, Inc VITROS Immunodiagnostic Products FSH Reagent Pack- IVD
1931922 Open, Classified |
CGJ | K964720 |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS FSH, REF 30407-01 Open, Classified |
CGJ | None listed |
| Jul 12, 2018 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products - FSH Reagent Pack
(10758750000302) 1931922 Open, Classified |
CGJ | K964720 |
| Jun 29, 2018 | BioMerieux SA VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France.
For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitati Terminated |
CGJ | K921746 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK FSH; Part Number: 025265
Assay, Reproductive Hormone Terminated |
CGJ | None listed |
| Dec 16, 2016 | PerkinElmer Health Sciences, Inc. DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum Terminated |
CGJ | K862043 |
| Jan 7, 2013 | Applied Medical Resources Corp Laparoscope, general; plastic surgery
Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue plan Terminated |
CGJ | K072674 |
| Sep 19, 2012 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B
US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack )
OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack)
Product Usage:
ADVIA Centaur CP Terminated |
CGJ | K904714 |
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