Ace Activity Microvial Test Set
FDA 510(k) K821011 · Ventrex Laboratories, Inc.
510(k) numberK821011
Submission
- Device name
- Ace Activity Microvial Test Set
- Applicant
- Ventrex Laboratories, Inc.
Mchenry, IL, US - Received
- April 12, 1982
- Decision date
- May 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K942497 | Angiotensin Converting Enzyme ReaKQN · Traditional | American Laboratory Products Co., Ltd. | 11/15/1994SE |
| 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 |
| K791712 | Angiotensin Converting Enzyme Assay SysKQN · Traditional | Ventrex Laboratories, Inc. | 09/19/1979SE |
More from Ventrex Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | 10/25/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Ace Activity Microvial Test Set cleared by the FDA?
Ace Activity Microvial Test Set (K821011) received a 510(k) decision of Substantially Equivalent on May 3, 1982, 21 days after the submission was received.
What is the product code of K821011?
The FDA product code is KQN – Radioassay, Angiotensin Converting Enzyme, a Class II (moderate risk) device regulated under 21 CFR 862.1090.