Radioassay, Angiotensin Converting Enzyme
This device is a radioassay for angiotensin converting enzyme (ACE), an in vitro diagnostic test used to measure ACE levels in serum or other biological fluids, primarily as an aid in the diagnosis and monitoring of sarcoidosis and other granulomatous diseases. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQN, regulated under 21 CFR 862.1090 within the Clinical Chemistry specialty. No special flags apply.
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Basic Information
- Product Code
- KQN
- Device Class
- FDA class 2
- Regulation Number
- 862.1090
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K041657 | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT | Aug 30, 2004 | Substantially Equivalent | Thermo Electron Corporation |
| K942497 | ANGIOTENSIN CONVERTING ENZYME REA | Nov 15, 1994 | Substantially Equivalent | American Laboratory Products Co., Ltd. |
| K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | Aug 26, 1991 | Substantially Equivalent | American Laboratory Products Co., Ltd. |
| K854876 | ALDOSTERONE DIRECT RIA KIT | Mar 17, 1986 | Substantially Equivalent | Biotecx Laboratories, Inc. |
| K854245 | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | Jan 22, 1986 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K833933 | ACE COLOR TEST | Mar 23, 1984 | Substantially Equivalent | Hana Biologics, Inc. |
| K821011 | ACE ACTIVITY MICROVIAL TEST SET | May 03, 1982 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K791712 | ANGIOTENSIN CONVERTING ENZYME ASSAY SYS | Sep 19, 1979 | Substantially Equivalent | Ventrex Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.