Atlas FDA

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

JKR — Predicate Candidate Screening

20 FDA 510(k) clearances under this product code; the 50 most recent screened below.

86 daysmedian FDA review time
266 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252431Elecsys CalcitoninRoche Diagnostics GmbH2026-04-242660
K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited2018-12-211470
K132828ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYSRoche Diagnostics2013-12-04860
K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSIScantibodies Laboratory, Inc.2006-08-301770
K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2Diagnostic Products Corp.2002-12-09671
K990073CALCITONINKmi Diagnostics, Inc.1999-05-111200
K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITSangui Biotech, Inc.1998-09-03481
K964635NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KITNichols Institute Diagnostics1997-05-211830
K961043SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEADScantibodies Laboratory, Inc.1996-05-06530
K945961CALCITONIN IMMUNOASSAY KITNichols Institute Diagnostics1995-11-203480
K951708ELSA-HCTCis-Us, Inc.1995-09-051450
K914429DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)Diagnostic Systems Laboratories, Inc.1992-01-151030
K912536CALCITONIN KIT MITSUBISHI YUKAMitsubishi Yuka America, Inc.1991-07-18410
K874087MODIFIED CALCITONIN RIA KIT DSL #1200Diagnostic Systems Laboratories, Inc.1988-02-021180
K872880CALCITONIN RIA KITEndocrine Associates, Inc.1987-08-13230
K861274DOUBLE ANTIBODY CALCITONIN RIA KITDiagnostic Products Corp.1986-06-25790
K854240CALCITONIN RIA KITDiagnostic Systems Laboratories, Inc.1985-11-22320
K842907CALCITONIN RADIOIMMUNOASSAY KITNichols Institute Diagnostics1984-09-05430
K821675CALCITONIN RIA TEST KIT, DLS 1200Diagnostic Systems Laboratories, Inc.1982-06-22140
K781909CALCITONIN 125Cambridge Nuclear Radiopharmaceutical1979-01-10570

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