Angiotensin Converting Enzyme Rea
FDA 510(k) K942497 · American Laboratory Products Co., Ltd.
510(k) numberK942497
Submission
- Device name
- Angiotensin Converting Enzyme Rea
- Applicant
- American Laboratory Products Co., Ltd.
Windham, NH, US - Received
- May 17, 1994
- Decision date
- November 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KQN – Radioassay, Angiotensin Converting Enzyme
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1090
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041657 | Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) ReagentKQN · Traditional | Thermo Electron Corporation | 08/30/2004SE |
| K913091 | Buehlmann Lab AS, Ace Angio Conv Enzyme Kin AssayKQN · Traditional | American Laboratory Products Co., Ltd. | 08/26/1991SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | Biotecx Laboratories, Inc. | 03/17/1986SE |
| K854245 | Sigma Angiotensin Converting Enzyme 305-UVKQN · Traditional | Sigma Diagnostics, Inc. | 01/22/1986SE |
| K833933 | Ace Color TestKQN · Traditional | Hana Biologics, Inc. | 03/23/1984SE |
| K821011 | Ace Activity Microvial Test SetKQN · Traditional | Ventrex Laboratories, Inc. | 05/03/1982SE |
| K791712 | Angiotensin Converting Enzyme Assay SysKQN · Traditional | Ventrex Laboratories, Inc. | 09/19/1979SE |
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| K962062 | Orgentec Anti-Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962057 | Orgentec Anti-Rnp/Sm ElisaLJM · Traditional | 11/18/1996SE |
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Questions and answers
When was Angiotensin Converting Enzyme Rea cleared by the FDA?
Angiotensin Converting Enzyme Rea (K942497) received a 510(k) decision of Substantially Equivalent on November 15, 1994, 182 days after the submission was received.
What is the product code of K942497?
The FDA product code is KQN – Radioassay, Angiotensin Converting Enzyme, a Class II (moderate risk) device regulated under 21 CFR 862.1090.