Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Microgenics Corporation — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

147 daysmedian FDA review time
241 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243498Alinity c Benzodiazepines Reagent KitMicrogenics Corporation2024-12-11290
K240670DRI Ecstasy Plus AssayMicrogenics Corporation2024-10-302330
K231020Alinity c Tricyclic Antidepressants Reagent KitMicrogenics Corporation2023-11-172210
K231007CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation2023-09-271730
K213875DRI TM Tricyclics Serum Tox AssayMicrogenics Corporation2022-12-213730
K211973DRI Cocaine Metabolite AssayMicrogenics Corporation2021-09-24910
K192943CEDIA Heroin Metabolite (6-AM) assayMicrogenics Corporation2019-12-16590
K190968CEDIA Benzodiazepine AssayMicrogenics Corporation2019-12-092410
DEN180030QMS Plazomicin ImmunoassayMicrogenics Corporation2018-11-191470
K181499DRI Cocaine Metabolite AssayMicrogenics Corporation2018-07-06290
K173963DRI Benzodiazepine AssayMicrogenics Corporation2018-02-21550
K173195DRI Hydrocodone AssayMicrogenics Corporation2018-02-131340
K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation2017-11-22510
K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II CalibraMicrogenics Corporation2017-04-061500
K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI HydrMicrogenics Corporation2015-10-092250
K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics Corporation2013-06-052030
K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMMicrogenics Corporation2012-12-132600
K122291THERMO SCIENTIFIC MAS OMNI-CARDIOMicrogenics Corporation2012-08-31310
K110738THERMO SCIENTIFIC MAS OMNI-COREMicrogenics Corporation2011-11-032310
K103656THERMO SCIENTIFIC MAS R DOA TOTALMicrogenics Corporation2011-03-24990
K092749MAS AND MINI-TROL PTH CONTROLMicrogenics Corporation2009-12-03860

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