Atlas FDA

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

Livonia Diagnostics, Inc. · Predicate Candidate Screening

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

21 daysmedian FDA review time
35 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K852161SERUM IRON/VIBC REAGENT SETLivonia Diagnostics, Inc.1985-06-10210
K844322SGOT REAGENT SETLivonia Diagnostics, Inc.1984-11-27200
K844283SGPT REAGENT SETLivonia Diagnostics, Inc.1984-11-27220
K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.1984-11-20190
K844156UREA NITROGEN REAGENT SETLivonia Diagnostics, Inc.1984-11-13200
K844182INORGANIC PHOSPHORUS REAGENT SETLivonia Diagnostics, Inc.1984-11-09140
K843894HDL PRECIPATATING REAGENT SETLivonia Diagnostics, Inc.1984-11-02300
K843895TOTAL CALCIUM REAGENT SETLivonia Diagnostics, Inc.1984-10-30270
K843893MAGNESIUM REAGENT SETLivonia Diagnostics, Inc.1984-10-30270
K844075URIC ACID REAGENT SETLivonia Diagnostics, Inc.1984-10-30110
K844024CREATININE REAGENT SETLivonia Diagnostics, Inc.1984-10-30150
K843831ALBUMIN REAGENT SETLivonia Diagnostics, Inc.1984-10-11100
K843701TOTAL PROTEIN REAGENT SETLivonia Diagnostics, Inc.1984-10-01100
K843222ENZYMATIC CHOLESTEROL KITLivonia Diagnostics, Inc.1984-09-28430
K843528GLUCOSE OXIDASE ENZYMATIC REAGENT SETLivonia Diagnostics, Inc.1984-09-28210
K842368SICKLE CELL REAGENT SETLivonia Diagnostics, Inc.1984-07-20350

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