510(k) K041657
- Device
- THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
- Applicant
- THERMO ELECTRON CORPORATION
- 510(k) number
- K041657
- Product code
- KQN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-30
- Date received
- 2004-06-18
- Regulation
- 862.1090
- Classification name
- Radioassay, Angiotensin Converting Enzyme
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BOLA NICHOLSON
- Address
- 331 S. 104th St. Louisville CO US 80027 80027
FDA Registration Numbers#
- 3002809144
- 3014325803
- 1000191380
- 9681576
- 9681753
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KQN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942497 | ANGIOTENSIN CONVERTING ENZYME REA | American Laboratory Products Co., Ltd. | 1994-11-15 |
| K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | American Laboratory Products Co., Ltd. | 1991-08-26 |
| K854876 | ALDOSTERONE DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1986-03-17 |
| K854245 | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | Sigma Diagnostics, Inc. | 1986-01-22 |
| K833933 | ACE COLOR TEST | Hana Biologics, Inc. | 1984-03-23 |
| K821011 | ACE ACTIVITY MICROVIAL TEST SET | Ventrex Laboratories, Inc. | 1982-05-03 |
| K791712 | ANGIOTENSIN CONVERTING ENZYME ASSAY SYS | Ventrex Laboratories, Inc. | 1979-09-19 |
Legacy Summary#
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FDA Review#
Decision Summary