Atlas FDA

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

Immuno-Products Industries · Predicate Candidate Screening

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

18 daysmedian FDA review time
51 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDImmuno-Products Industries1985-09-19560
K852231ANA/LITE-HEP-2 TEST SYSTEMImmuno-Products Industries1985-07-10490
K852230ANA/LITE-RL TEST SYSTEMImmuno-Products Industries1985-07-10490
K843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBImmuno-Products Industries1984-10-31510
K831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBImmuno-Products Industries1983-04-27260
K830652ANTI N DNA-HCPImmuno-Products Industries1983-03-24170
K821576ANTINUCLEAR ANTIBODY SCREEN FLOURESCImmuno-Products Industries1982-06-10130
K810984ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TESTImmuno-Products Industries1981-05-01180
K810983ANTISMOOTH MUSCLE ANTIBODY TEST SYSImmuno-Products Industries1981-05-01180
K810982ANTITHYROID ANTIBODY IMMUNOFLUORESCENTImmuno-Products Industries1981-05-01180
K810985ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENTImmuno-Products Industries1981-05-01180
K810981ANTI NDNA IMMUNOFLOURESCENT TEST SYSImmuno-Products Industries1981-04-29160

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