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

Dade Chemistry Systems, Inc. · Predicate Candidate Screening

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

31 daysmedian FDA review time
91 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973650TROPONIN (TROP) METHODDade Chemistry Systems, Inc.1997-10-20250
K973099PROSTATE SPECIFIC ANTIGEN CONTROLDade Chemistry Systems, Inc.1997-09-29410
K973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORDade Chemistry Systems, Inc.1997-09-29410
K973101PROSTATE SPECIFIC ANTIGEN METHODDade Chemistry Systems, Inc.1997-09-18300
K971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMDade Chemistry Systems, Inc.1997-04-28310
K970387HUMAN CHORIONIC GONADOTROPIN METHODDade Chemistry Systems, Inc.1997-03-10350
K970336MMB CALIBRATORDade Chemistry Systems, Inc.1997-03-03331
K970393THYROID STIMULATING HORMONE METHODDade Chemistry Systems, Inc.1997-03-03280
K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.1997-02-20170
K970389THYROID CALIBRATORDade Chemistry Systems, Inc.1997-02-18150
K970343MMB METHODDade Chemistry Systems, Inc.1997-02-14160
K963498FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.1997-01-241432
K963493FERRITIN CALIBRATORDade Chemistry Systems, Inc.1996-12-03910

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