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

Canyon Diagnostics, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time
60 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970248CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTCanyon Diagnostics, Inc.1997-02-11200
K964640CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBCanyon Diagnostics, Inc.1996-12-13240
K882488CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBESCanyon Diagnostics, Inc.1988-08-15600
K871537CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND IICanyon Diagnostics, Inc.1987-05-06160
K855006CANTROL CK/MB CONTROLCanyon Diagnostics, Inc.1986-01-17350
K854931CANTROL ELECTROPHORESIS CONTROLCanyon Diagnostics, Inc.1986-01-17380
K854190CANTROL SPINAL FLUID CONTROLCanyon Diagnostics, Inc.1985-11-25410
K853603CANTROL URINE DIPSTICK CONTROL TWO LEVELSCanyon Diagnostics, Inc.1985-10-08410
K852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, Inc.1985-06-13280

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