Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hybritech, Inc. — Predicate Candidate Screening
63 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
121 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1997-09-11 | 57 | 0 |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1996-08-19 | 118 | 0 |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1994-01-11 | 328 | 0 |
| K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET | Hybritech, Inc. | 1993-02-17 | 254 | 0 |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Hybritech, Inc. | 1992-07-30 | 108 | 0 |
| K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL | Hybritech, Inc. | 1992-07-17 | 123 | 0 |
| K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET | Hybritech, Inc. | 1992-07-17 | 162 | 0 |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1992-06-09 | 56 | 0 |
| K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET | Hybritech, Inc. | 1991-08-28 | 86 | 0 |
| K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1991-07-24 | 114 | 0 |
| K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1990-10-03 | 86 | 0 |
| K895094 | TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1989-10-31 | 78 | 0 |
| K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1989-09-13 | 48 | 0 |
| K884085 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1988-12-02 | 66 | 0 |
| K872131 | TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-08-25 | 82 | 0 |
| K872063 | TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II | Hybritech, Inc. | 1987-06-19 | 22 | 0 |
| K871235 | TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT | Hybritech, Inc. | 1987-06-03 | 68 | 0 |
| K870521 | TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY | Hybritech, Inc. | 1987-04-08 | 61 | 0 |
| K870520 | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-03-10 | 32 | 0 |
| K865057 | TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-03-10 | 76 | 0 |
| K864945 | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-01-05 | 19 | 0 |
| K863841 | TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE | Hybritech, Inc. | 1986-12-22 | 82 | 0 |
| K863859 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM | Hybritech, Inc. | 1986-11-21 | 49 | 0 |
| K863860 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN | Hybritech, Inc. | 1986-11-21 | 49 | 0 |
| K863861 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA | Hybritech, Inc. | 1986-11-21 | 49 | 0 |
| K863858 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- | Hybritech, Inc. | 1986-11-03 | 31 | 0 |
| K863345 | TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1986-10-08 | 40 | 0 |
| K862956 | ICON READER | Hybritech, Inc. | 1986-08-19 | 14 | 0 |
| K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | Hybritech, Inc. | 1986-08-15 | 32 | 0 |
| K860984 | TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT | Hybritech, Inc. | 1986-04-29 | 43 | 0 |
| K860778 | TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1986-04-04 | 32 | 0 |
| K860542 | TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1986-03-05 | 21 | 0 |
| K860221 | ENCORE PROLACTIN REAGENT | Hybritech, Inc. | 1986-03-05 | 42 | 0 |
| K853069 | TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1986-01-01 | 163 | 0 |
| K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER | Hybritech, Inc. | 1985-07-12 | 37 | 0 |
| K851950 | TANDEM E PAP | Hybritech, Inc. | 1985-06-25 | 53 | 0 |
| K850680 | ENCORE FERRITIN REAGENT | Hybritech, Inc. | 1985-03-21 | 28 | 0 |
| K850159 | TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1985-03-04 | 48 | 0 |
| K845024 | BAKER CKMB REAGENT SET | Hybritech, Inc. | 1985-01-18 | 22 | 0 |
| K843804 | TANDEM - EPRL | Hybritech, Inc. | 1984-11-13 | 47 | 0 |
| K843395 | ENCORE TSH REAGENT | Hybritech, Inc. | 1984-10-11 | 43 | 0 |
| K843407 | ENCORE HCG REAGENT | Hybritech, Inc. | 1984-10-04 | 34 | 0 |
| K843408 | ENCORE IGE REAGENT | Hybritech, Inc. | 1984-10-01 | 31 | 0 |
| K842633 | TANDEM FAST VISUAL HCG ASSAY KIT - | Hybritech, Inc. | 1984-08-23 | 45 | 0 |
| K834300 | HYBRITECH DATA STATION | Hybritech, Inc. | 1984-02-21 | 74 | 0 |
| K834000 | TANDEM VISUAL HCG IMMUNOENZYMETRIC | Hybritech, Inc. | 1984-02-03 | 74 | 0 |
| K833194 | TANDEM R-TOTAL B-GCG KIT | Hybritech, Inc. | 1984-01-18 | 121 | 0 |
| K832813 | TANDEM-E THYROID STIMULATING HORMONE KIT | Hybritech, Inc. | 1983-10-31 | 73 | 0 |
| K832397 | HYBRITECH 405-500 NM FILTER MODULE | Hybritech, Inc. | 1983-08-31 | 42 | 0 |
| K832364 | PHOTON IMMUNOASSAY ANALYZER | Hybritech, Inc. | 1983-08-26 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda