FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE ACTIVITY MICROVIAL TEST SET
K Number: K821011
·
Decision May 3, 1982
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
82
Review Days
21
Basic Information
- Device Name
- ACE ACTIVITY MICROVIAL TEST SET
- K Number
- K821011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1090
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- VENTREX LABORATORIES, INC.
- Date Received
- April 12, 1982
- Decision Date
- May 3, 1982
- Product Code
- KQN
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KQN | Radioassay, Angiotensin Converting Enzyme | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
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ACE COLOR TEST
FDA 510(k)
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Other Clearances by VENTREX LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K914554 | SPECIFIC IGE EIA-TURBO ASSAY | Mar 13, 1992 | Substantially Equivalent |
| K913833 | VENTREX ALLERGEN DISC | Feb 21, 1992 | Substantially Equivalent |
| K913434 | VENTREX COATED TUBE INTACT PTH | Oct 25, 1991 | Substantially Equivalent |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | Feb 21, 1991 | Substantially Equivalent |
| K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | Feb 7, 1991 | Substantially Equivalent |
| K905247 | SHBG IRMA KIT | Jan 17, 1991 | Substantially Equivalent |
| K904330 | TURBO-RAST SPECIFIC IGE ASSAY | Dec 7, 1990 | Substantially Equivalent |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Jul 31, 1990 | Substantially Equivalent |
| K897083 | VENTRESIGN STREP A TEST | Jan 22, 1990 | Substantially Equivalent |
| K895649 | COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. | Jan 18, 1990 | Substantially Equivalent |