Atlas FDA

CJM

12 FDA 510(k) clearances · Product code

78 daysmedian time to decision
187 days90th percentile
12clearances measured

FDA profile

Official device name
Radioimmunoassay, Aldosterone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1045
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (K142994)Immunodiagnostic Systems , Ltd.2015-04-21
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321)Diasorin2013-04-09
NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K050784)Nichols Institute Diagnostics2005-06-01
NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K032188)Nichols Institute Diagnostics2003-07-31
DSL ACTIVE ALDOSTERONE RIA (DSL 8600) (K943397)Diagnostic Systems Laboratories, Inc.1995-02-13
DSL ACTIVE ALDOSTERONE (DSL 8600) (K921205)Diagnostic Systems Laboratories, Inc.1992-07-10
RSL (125I) ALDOSTERONE KIT (K862204)Radioassay Systems Laboratories, Inc.1986-09-25
ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (K834428)Serono Laboratories, Inc.1984-03-02
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE (K831178)Diagnostic Products Corp.1983-05-27
ALDOCTK-125 (K800775)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
125I-ALDOSTERONE RIA DIAG. KIT (K781504)Abbott Laboratories1978-11-22
125 I ALDOSTERONE RIA KIT (K771526)Diagnostic Products Corp.1977-08-25

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