Atlas FDA

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

Sealite Sciences, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
163 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974551SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAYSealite Sciences, Inc.1997-12-22180
K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.1997-09-25630
K970612SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAYSealite Sciences, Inc.1997-06-241260
K970483AQUALITE INTACT PTHSealite Sciences, Inc.1997-04-14630
K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.1997-02-20340
K970085SEALITE SCIENCES AQUALITE FSHSealite Sciences, Inc.1997-02-14350
K964925SEALITE SCIENCES, INC. AQUALITE LHSealite Sciences, Inc.1997-01-22440
K942661AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KITSealite Sciences, Inc.1995-01-172250
K943437AQUALITE FSHSealite Sciences, Inc.1994-12-281630
K943188SEALITE SCIENCE, INC. AQUALITE(R) LHSealite Sciences, Inc.1994-10-201070
K941983SEALITE SCIENCES INC.Sealite Sciences, Inc.1994-08-181150

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