Product code KQN— Clinical Chemistry
ACE ACTIVITY MICROVIAL TEST SET
- Classification name
- Radioassay, Angiotensin Converting Enzyme
- Device class
- Class 2
- Regulation
- 21 CFR 862.1090
- Advisory panel
- Clinical Chemistry
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code KQN
FDA has cleared devices under product code KQN between 1979 and 2004, filed by 6 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
- 2004
- 1994
- 1991
- 1986
- 1984
- 1982
- 1979
Top applicants under product code KQN
Recent clearances under product code KQN
- K041657 — THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
- K942497 — ANGIOTENSIN CONVERTING ENZYME REA
- K913091 — BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY
- K854876 — ALDOSTERONE DIRECT RIA KIT
- K854245 — SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
- K833933 — ACE COLOR TEST
- K821011 — ACE ACTIVITY MICROVIAL TEST SET
- K791712 — ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
Data sourced from openFDA. This site is unofficial and independent of the FDA.