Atlas FDA

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

FDA 510(k) clearance K050784 · decided 2005-06-01

Clearance details

K-number
K050784
Device name
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
Applicant
Nichols Institute Diagnostics
Decision
Substantially Equivalent
Date received
2005-03-28
Decision date
2005-06-01
Days to decision
65 days
Clearance type
Traditional
Product code
CJM
Device class
2
Regulation number
862.1045
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
San Clemente, CA, US
Third-party review
Yes
Expedited review
No

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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

Recalls involving this device

No recalls on record reference this clearance.