Product code CJM— Clinical Chemistry
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- Classification name
- Radioimmunoassay, Aldosterone
- Device class
- Class 2
- Regulation
- 21 CFR 862.1045
- Advisory panel
- Clinical Chemistry
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code CJM
FDA has cleared devices under product code CJM between 1977 and 2015, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2013
- 2005
- 2003
- 1995
- 1992
- 1986
- 1984
- 1983
- 1980
- 1978
- 1977
Top applicants under product code CJM
Recent clearances under product code CJM
- K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
- K130321 — LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
- K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K943397 — DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
- K921205 — DSL ACTIVE ALDOSTERONE (DSL 8600)
- K862204 — RSL (125I) ALDOSTERONE KIT
- K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT
- K831178 — COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
- K800775 — ALDOCTK-125
- K781504 — 125I-ALDOSTERONE RIA DIAG. KIT
- K771526 — 125 I ALDOSTERONE RIA KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.