ACE ACTIVITY MICROVIAL TEST SET
FDA 510(k) clearance K821011 · decided 1982-05-03
Clearance details
- K-number
- K821011
- Device name
- ACE ACTIVITY MICROVIAL TEST SET
- Applicant
- Ventrex Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-12
- Decision date
- 1982-05-03
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KQN
- Device class
- 2
- Regulation number
- 862.1090
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (K041657) | Thermo Electron Corporation | 2004-08-30 |
| ANGIOTENSIN CONVERTING ENZYME REA (K942497) | American Laboratory Products Co., Ltd. | 1994-11-15 |
| BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (K913091) | American Laboratory Products Co., Ltd. | 1991-08-26 |
| ALDOSTERONE DIRECT RIA KIT (K854876) | Biotecx Laboratories, Inc. | 1986-03-17 |
| SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (K854245) | Sigma Diagnostics, Inc. | 1986-01-22 |
| ACE COLOR TEST (K833933) | Hana Biologics, Inc. | 1984-03-23 |
| ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (K791712) | Ventrex Laboratories, Inc. | 1979-09-19 |
Recalls involving this device
No recalls on record reference this clearance.