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

Genetic Systems Corp. — Predicate Candidate Screening

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

38 daysmedian FDA review time
123 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K891767GENETIC SYSTEMS MICROPLATE READERGenetic Systems Corp.1989-07-251230
K891768GENETIC SYSTEMS MICROPLATE WASHERGenetic Systems Corp.1989-05-01380
K891766GENETIC SYSTEMS MICROPLATE STRIP WASHERGenetic Systems Corp.1989-05-01380
K891765GENETIC SYSTEMS PIPETTOR/DILUTORGenetic Systems Corp.1989-05-01380
K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.1989-03-21340
K873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDESGenetic Systems Corp.1987-11-20790
K873542MICROPLATE AUTO-WASHER (MOTORIZED STAGE)Genetic Systems Corp.1987-09-23220
K870176GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.1987-07-161821
K870879ALANINE TRANSAMINASE (ALT) TEST KITGenetic Systems Corp.1987-03-19150
K863566GSC 1000Genetic Systems Corp.1986-10-16340
K852237LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KITGenetic Systems Corp.1985-08-22920
K842683GENETIC SYS LEGIONELLA IMMUNOFLURORESGenetic Systems Corp.1984-08-02230

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