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

Gelco Diagnostics, Inc. — Predicate Candidate Screening

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

123 daysmedian FDA review time
123 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832262FITC GOAT ANTI-HUMAN IMMUNOGLOBULINSGelco Diagnostics, Inc.1983-10-311230
K832258GOAT ANTI-HUMAN IGG Y CHAIN SPECIFICGelco Diagnostics, Inc.1983-10-311230
K832267FITC GOAT ANTI-HUMAN LAMBAGelco Diagnostics, Inc.1983-10-311230
K832266FITC GOAT ANTI-HUMAN KAPPA AFFINITYGelco Diagnostics, Inc.1983-10-311230
K832260GOAT ANTI-HUMAN KAPPA AFFINITYGelco Diagnostics, Inc.1983-10-311230
K832265FITC GOAT ANTI-HUMAN IGM H CHAINGelco Diagnostics, Inc.1983-10-311230
K832256GOAT ANTI-HUMAN IMMUNOGLOBULINS-Gelco Diagnostics, Inc.1983-10-311230
K832263FITC GOAT ANTI-HUMAN IGA A CHAINGelco Diagnostics, Inc.1983-10-311230
K832270GOAT ANTI-HUMAN LAMBAGelco Diagnostics, Inc.1983-10-311230
K832261GOAT ANTI-HUMAN LAMBA AFFINITYGelco Diagnostics, Inc.1983-10-281200
K832259GOAT ANTI-HUMAN IGM H CHAINGelco Diagnostics, Inc.1983-10-281200
K832257GOAT ANTI-HUMAN IGA A CHAIN SPECIFICGelco Diagnostics, Inc.1983-10-281200
K832264FITC GOAT ANTI-HUMAN IGG Y CHAINGelco Diagnostics, Inc.1983-10-281200
K832268RABBIT ANTI-HUMAN ANTITHROMBIN IIIGelco Diagnostics, Inc.1983-08-12430

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