Hybritech, Inc.
Medical device manufacturer in San Diego, CA.
63510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 14
- JHY Colorimetric Method, Cpk Or Isoenzymes 5
- JFH Acid Phosphatase (Prostatic), Tartrate… 4
- JJX Single (Specified) Analyte Controls… 4
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 4
- CFT Radioimmunoassay, Prolactin (Lactogen) 4
- DGC Ige, Antigen, Antiserum, Control 4
- DBF Ferritin, Antigen, Antiserum, Control 3
- CEP Radioimmunoassay, Luteinizing Hormone 3
- CIN Electrophoretic Separation, Alkaline… 3
- JJQ Colorimeter, Photometer, Spectrophotometer… 2
- GTZ Antisera, All Groups, Streptococcus Spp. 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 2
- CFL Radioimmunoassay, Human Growth Hormone 1
- JQP Calculator/Data Processing Module, For… 1
- JMB Visual, Semi-Quant. (Colorimetric)… 1
- JJF Analyzer, Chemistry, Micro, For Clinical Use 1
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 1
- JZT Fluorometer 1
- JQT Densitometer/Scanner (Integrating… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 08/19/1996SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
| K902991 | Icon Strep B Immunoenzymetric AssayGTY · Traditional | 10/03/1990SE |
| K895094 | Tandem-E LH Immunoenzymetric Assay KitCEP · Traditional | 10/31/1989SE |
| K894761 | Tandem-E FSH Immunoenzymetric Assay KitCGJ · Traditional | 09/13/1989SE |
| K884085 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 12/02/1988SE |
| K872131 | Tandemr M-Pak LH Immunoenzymetric AssayCEP · Traditional | 08/25/1987SE |
| K872063 | Tandem-E Immunoenzymetric Assay for CKMB IIJHY · Traditional | 06/19/1987SE |
| K871235 | Tandem(R) Icon(R) Qsr(Tm) HCG Immuno. Assay KitJHI · Traditional | 06/03/1987SE |
| K870521 | Tandem(R) M-Pak(Tm) Total B-Hcg Immunoenzy. AssayJHI · Traditional | 04/08/1987SE |
| K870520 | Tandem(R)-M FSH Immunoenzymetric AssayCGJ · Traditional | 03/10/1987SE |
| K865057 | Tandemr Iconr II Hcg(Serum) Immunoenzymetric AssayJHI · Traditional | 03/10/1987SE |
| K864945 | Tandem(R) M-Pak(Tm) Pap Immunoenzymetric AssayJFH · Traditional | 01/05/1987SE |
| K863841 | Tandem OTC HCG Pregnancy Test for Consumer UseLCX · Traditional | 12/22/1986SE |
| K863861 | Tandem-M Immunoenzymetric Assay for Hum/Chor/GonaJHI · Traditional | 11/21/1986SE |
| K863860 | Tandem-M Immunoenzymetric Assay for ProlactinCFT · Traditional | 11/21/1986SE |
| K863859 | Tandem-M Immunoenzymetric Assay for Thyr/Stim/HormJLW · Traditional | 11/21/1986SE |
| K863858 | Tandem-M Immunoenzymetric Assay for Ige--DGC · Traditional | 11/03/1986SE |
| K863345 | Tandem(R)-M Ferritin Immunoenzymetric AssayDBF · Traditional | 10/08/1986SE |
| K862956 | Icon ReaderJQT · Traditional | 08/19/1986SE |
| K862674 | Photon Elite/Automated Random Access Im/Ch SystemJZT · Traditional | 08/15/1986SE |
| K860984 | Tandem Icon LH Assay (Urine) Immunoenzymetric KitCEP · Traditional | 04/29/1986SE |
| K860778 | Tandem Icon Strep a Immunoenzymetric Assay KitGTZ · Traditional | 04/04/1986SE |
| K860542 | Tandem Icon II HCG Immunoenzymetric Assay KitJHI · Traditional | 03/05/1986SE |
| K860221 | Encore Prolactin ReagentCFT · Traditional | 03/05/1986SE |
| K853069 | Tandem Icon Rubella Igg Immunoenzymetric Assay KitLFX · Traditional | 01/01/1986SE |
| K852385 | Hybritech Immunochemistry AnalyzerJJF · Traditional | 07/12/1985SE |
| K851950 | Tandem E PapJFH · Traditional | 06/25/1985SE |
| K850680 | Encore Ferritin ReagentJMB · Traditional | 03/21/1985SE |
| K850159 | Tandem Icon HCG Immunoenzymetric Assay KitJHI · Traditional | 03/04/1985SE |
| K845024 | Baker CKMB Reagent SetJHY · Traditional | 01/18/1985SE |
| K843804 | Tandem - EprlCFT · Traditional | 11/13/1984SE |
| K843395 | Encore TSH ReagentJLW · Traditional | 10/11/1984SE |
| K843407 | Encore HCG ReagentJHI · Traditional | 10/04/1984SE |
| K843408 | Encore Ige ReagentDGC · Traditional | 10/01/1984SE |
| K842633 | Tandem Fast Visual HCG Assay Kit -JHI · Traditional | 08/23/1984SE |
| K834300 | Hybritech Data StationJQP · Traditional | 02/21/1984SE |
| K834000 | Tandem Visual HCG ImmunoenzymetricJHI · Traditional | 02/03/1984SE |
| K833194 | Tandem R-Total B-Gcg KitJHI · Traditional | 01/18/1984SE |
| K832813 | Tandem-E Thyroid Stimulating Hormone KitJLW · Traditional | 10/31/1983SE |
| K832397 | Hybritech 405-500 NM Filter ModuleJJQ · Traditional | 08/31/1983SE |
| K832364 | Photon Immunoassay AnalyzerJJQ · Traditional | 08/26/1983SE |
| K832139 | Tandem - E-Ckmb Immunoenzymetric AssayJHY · Traditional | 08/12/1983SE |
| K823871 | Tandem-E -Fer Immunoenzymetric KitDBF · Traditional | 02/25/1983SE |
| K830138 | Tandem E GCG Visual End Point InnumoenzJHI · Traditional | 02/07/1983SE |
| K823507 | Tandem-E -Ige Immunoezymetric AssayDGC · Traditional | 12/28/1982SE |
| K822705 | Tamdem-R Thyroid Stimulating Hormone KitJLW · Traditional | 10/13/1982SE |
| K821944 | Tandem HCG Immunoezymetric Assay KitJHI · Traditional | 07/22/1982SE |
| K821545 | Tandem Prolactin KitCFT · Traditional | 06/11/1982SE |
| K821366 | Tandem - HGH KitCFL · Traditional | 06/10/1982SE |
| K820822 | Tandem HCG KitJHI · Traditional | 04/29/1982SE |
| K812597 | Ferritin KitDBF · Traditional | 10/19/1981SE |
| K812461 | Tandem Qualitative HCG KitJHI · Traditional | 10/13/1981SE |
| K811959 | Tandem Pap Kit - (Parts I & II)JFH · Traditional | 09/01/1981SE |
| K802913 | Tan Dem* - Ige KitDGC · Traditional | 05/29/1981SE |