Hybritech, Inc.
Mchenry, IL, US
Hybritech, Inc. appears in FDA device records in Mchenry, IL. FDA records list 63 510(k) clearances between and , 12 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 63
- PMA records
- 12
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 63FDA records hold 63 510(k) clearances for Hybritech, Inc. between 1981 and 1997. The busiest year on record is 1986, with 13. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 4 |
| 1982 | 6 |
| 1983 | 6 |
| 1984 | 8 |
| 1985 | 5 |
| 1986 | 13 |
| 1987 | 7 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 4 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | CIN | Substantially Equivalent | |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | CIN | Substantially Equivalent | |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | CIN | Substantially Equivalent | |
| K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET | JJX | Substantially Equivalent | |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | JFH | Substantially Equivalent | |
| K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL | JJX | Substantially Equivalent | |
| K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET | JJX | Substantially Equivalent | |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | JHY | Substantially Equivalent | |
| K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET | JJX | Substantially Equivalent | |
| K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY | GTZ | Substantially Equivalent | |
| K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY | GTY | Substantially Equivalent | |
| K895094 | TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT | CEP | Substantially Equivalent | |
| K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT | CGJ | Substantially Equivalent | |
| K884085 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | JHY | Substantially Equivalent | |
| K872131 | TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY | CEP | Substantially Equivalent | |
| K872063 | TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II | JHY | Substantially Equivalent | |
| K871235 | TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT | JHI | Substantially Equivalent | |
| K870521 | TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY | JHI | Substantially Equivalent | |
| K870520 | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY | CGJ | Substantially Equivalent | |
| K865057 | TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY | JHI | Substantially Equivalent | |
| K864945 | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | JFH | Substantially Equivalent | |
| K863841 | TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE | LCX | Substantially Equivalent | |
| K863861 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA | JHI | Substantially Equivalent | |
| K863860 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN | CFT | Substantially Equivalent | |
| K863859 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM | JLW | Substantially Equivalent | |
| K863858 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- | DGC | Substantially Equivalent | |
| K863345 | TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY | DBF | Substantially Equivalent | |
| K862956 | ICON READER | JQT | Substantially Equivalent | |
| K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | JZT | Substantially Equivalent | |
| K860984 | TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT | CEP | Substantially Equivalent | |
| K860778 | TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT | GTZ | Substantially Equivalent | |
| K860542 | TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT | JHI | Substantially Equivalent | |
| K860221 | ENCORE PROLACTIN REAGENT | CFT | Substantially Equivalent | |
| K853069 | TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT | LFX | Substantially Equivalent | |
| K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER | JJF | Substantially Equivalent | |
| K851950 | TANDEM E PAP | JFH | Substantially Equivalent | |
| K850680 | ENCORE FERRITIN REAGENT | JMB | Substantially Equivalent | |
| K850159 | TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT | JHI | Substantially Equivalent | |
| K845024 | BAKER CKMB REAGENT SET | JHY | Substantially Equivalent | |
| K843804 | TANDEM - EPRL | CFT | Substantially Equivalent | |
| K843395 | ENCORE TSH REAGENT | JLW | Substantially Equivalent | |
| K843407 | ENCORE HCG REAGENT | JHI | Substantially Equivalent | |
| K843408 | ENCORE IGE REAGENT | DGC | Substantially Equivalent | |
| K842633 | TANDEM FAST VISUAL HCG ASSAY KIT - | JHI | Substantially Equivalent | |
| K834300 | HYBRITECH DATA STATION | JQP | Substantially Equivalent | |
| K834000 | TANDEM VISUAL HCG IMMUNOENZYMETRIC | JHI | Substantially Equivalent | |
| K833194 | TANDEM R-TOTAL B-GCG KIT | JHI | Substantially Equivalent | |
| K832813 | TANDEM-E THYROID STIMULATING HORMONE KIT | JLW | Substantially Equivalent | |
| K832397 | HYBRITECH 405-500 NM FILTER MODULE | JJQ | Substantially Equivalent | |
| K832364 | PHOTON IMMUNOASSAY ANALYZER | JJQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- JQPCalculator/Data Processing Module, For Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JHYColorimetric Method, Cpk Or Isoenzymes
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- DBFFerritin, Antigen, Antiserum, Control
- JZTFluorometer
- DGCIge, Antigen, Antiserum, Control
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHXSystem, Test, Carcinoembryonic Antigen
- JHIVisual, Pregnancy Hcg, Prescription Use
- JMBVisual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain