Atlas FDA

JKR

20 FDA 510(k) clearances · Product code

86 daysmedian time to decision
266 days90th percentile
20clearances measured

FDA profile

Official device name
Radioimmunoassay, Calcitonin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1140
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
Elecsys Calcitonin (K252431)Roche Diagnostics GmbH2026-04-24
ADVIA Centaur Calcitonin (CALCT) assay (K182012)Axis-Shield Diagnostics Limited2018-12-21
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 (K132828)Roche Diagnostics2013-12-04
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (K060578)Scantibodies Laboratory, Inc.2006-08-30
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL (K023304)Diagnostic Products Corp.2002-12-09
CALCITONIN (K990073)Kmi Diagnostics, Inc.1999-05-11
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (K982491)Sangui Biotech, Inc.1998-09-03
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT (K964635)Nichols Institute Diagnostics1997-05-21
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (K961043)Scantibodies Laboratory, Inc.1996-05-06
CALCITONIN IMMUNOASSAY KIT (K945961)Nichols Institute Diagnostics1995-11-20
ELSA-HCT (K951708)Cis-Us, Inc.1995-09-05
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (K914429)Diagnostic Systems Laboratories, Inc.1992-01-15
CALCITONIN KIT MITSUBISHI YUKA (K912536)Mitsubishi Yuka America, Inc.1991-07-18
MODIFIED CALCITONIN RIA KIT DSL #1200 (K874087)Diagnostic Systems Laboratories, Inc.1988-02-02
CALCITONIN RIA KIT (K872880)Endocrine Associates, Inc.1987-08-13
DOUBLE ANTIBODY CALCITONIN RIA KIT (K861274)Diagnostic Products Corp.1986-06-25
CALCITONIN RIA KIT (K854240)Diagnostic Systems Laboratories, Inc.1985-11-22
CALCITONIN RADIOIMMUNOASSAY KIT (K842907)Nichols Institute Diagnostics1984-09-05
CALCITONIN RIA TEST KIT, DLS 1200 (K821675)Diagnostic Systems Laboratories, Inc.1982-06-22
CALCITONIN 125 (K781909)Cambridge Nuclear Radiopharmaceutical1979-01-10

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Every clearance here is in the API, with alerts when new ones post.