Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microgenics Corp. — Predicate Candidate Screening
107 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
253 days90th percentile
107clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | Microgenics Corp. | 2013-08-20 | 344 | 1 |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Microgenics Corp. | 2013-07-11 | 253 | 1 |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | Microgenics Corp. | 2013-04-26 | 189 | 0 |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | Microgenics Corp. | 2011-06-29 | 118 | 3 |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K100144 | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND C | Microgenics Corp. | 2011-02-11 | 388 | 0 |
| K093114 | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY | Microgenics Corp. | 2010-05-12 | 223 | 0 |
| K092051 | THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED | Microgenics Corp. | 2009-09-21 | 76 | 0 |
| K090810 | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES | Microgenics Corp. | 2009-09-18 | 177 | 0 |
| K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL | Microgenics Corp. | 2006-05-30 | 32 | 2 |
| K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS | Microgenics Corp. | 2006-02-03 | 58 | 0 |
| K051074 | MAS IMMUNOSUPPRESSANT CONTROLS | Microgenics Corp. | 2005-06-06 | 40 | 0 |
| K050206 | CEDIA TACROLIMUS ASSAY | Microgenics Corp. | 2005-03-15 | 46 | 0 |
| DEN040008 | CEDIA SIROLIMUS ASSAY | Microgenics Corp. | 2004-07-28 | 41 | 0 |
| K040316 | CEDIA BUPRENORPHINE ASSAY | Microgenics Corp. | 2004-06-23 | 135 | 0 |
| K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT | Microgenics Corp. | 2004-05-28 | 64 | 0 |
| K040411 | DRI OXYCODONE ASSAY | Microgenics Corp. | 2004-05-27 | 99 | 0 |
| K041073 | DOCUMENT SALICYLATE CAL VER | Microgenics Corp. | 2004-05-21 | 25 | 0 |
| K032811 | CEDIA VANCOMYCIN ASSAY | Microgenics Corp. | 2003-11-24 | 76 | 0 |
| K032842 | MICROGENICS CYCLOSPORINE CONTROL KIT | Microgenics Corp. | 2003-10-17 | 36 | 0 |
| K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | Microgenics Corp. | 2003-08-27 | 302 | 0 |
| K030649 | DRI COTININE EIA ASSAY | Microgenics Corp. | 2003-05-22 | 83 | 0 |
| K030616 | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 | Microgenics Corp. | 2003-03-31 | 33 | 0 |
| K023780 | DRI PRIMIDONE CALIBRATORS | Microgenics Corp. | 2003-02-10 | 90 | 0 |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Microgenics Corp. | 2002-10-24 | 29 | 0 |
| K012109 | DRI ECSTASY URINE CALIBRATORS | Microgenics Corp. | 2001-08-27 | 52 | 0 |
| K012110 | DRI ECSTASY ENZYME IMMUNOASSAY | Microgenics Corp. | 2001-08-27 | 52 | 0 |
| K011150 | DRIDAU OPIATE ASSAY | Microgenics Corp. | 2001-06-20 | 65 | 0 |
| K010496 | CEDIA DAU AMPHETAMINES/ECSTASY ASSAY | Microgenics Corp. | 2001-05-29 | 97 | 0 |
| K001178 | CEDIA DAU 6-ACETYLMORPHINE ASSAY | Microgenics Corp. | 2000-06-09 | 59 | 0 |
| K994380 | CEDIA DAU AMPHASSURE ASSAY | Microgenics Corp. | 2000-05-02 | 127 | 0 |
| K955813 | CEDIA DAU LSD CALBIRATORS | Microgenics Corp. | 1996-02-09 | 45 | 0 |
| K955814 | CEDIA DAU LSD ASSAY | Microgenics Corp. | 1996-02-09 | 45 | 0 |
| K954626 | CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION) | Microgenics Corp. | 1995-11-27 | 55 | 0 |
| K954227 | CEDIA DAU METHADONE ASSAY | Microgenics Corp. | 1995-11-17 | 67 | 0 |
| K951134 | CEDIA VITAMIN B12 (NO BOIL) ASSAY | Microgenics Corp. | 1995-07-11 | 120 | 0 |
| K951155 | CEDIA FOLATE (NO BOIL) ASSAY | Microgenics Corp. | 1995-06-29 | 107 | 0 |
| K951710 | CEDIA DAU BENZODIAZEPINE ASSAY | Microgenics Corp. | 1995-06-20 | 67 | 0 |
| K951154 | CEDIA DAU AMPHETAMINES ASSAY | Microgenics Corp. | 1995-05-08 | 55 | 0 |
| K951133 | CEDIA DAU PROPOXYPHENE ASSAY | Microgenics Corp. | 1995-05-02 | 50 | 0 |
| K951153 | CEDIA DAU PPX/METH CALIBRATOR | Microgenics Corp. | 1995-04-21 | 38 | 0 |
| K951135 | MULTI-DRUG CONTROL SET | Microgenics Corp. | 1995-04-13 | 31 | 0 |
| K945343 | CEDIA DAU OPIATE ASSAY | Microgenics Corp. | 1995-01-17 | 77 | 0 |
| K946059 | CEDIA(R) DAU PCP ASSAY | Microgenics Corp. | 1995-01-17 | 36 | 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