FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URICACID
K Number: K821741
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
21
Review Days
18
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Basic Information
- Device Name
- URICACID
- K Number
- K821741
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodynamics Corp.
- Date Received
- June 14, 1982
- Decision Date
- July 2, 1982
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNK), ordered by most recent decision date.
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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
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Other Clearances by Biodynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER | Mar 16, 2006 | Substantially Equivalent |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | Nov 17, 1988 | Substantially Equivalent |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | Sep 9, 1988 | Substantially Equivalent |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | Jul 28, 1988 | Substantially Equivalent |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | Mar 16, 1988 | Substantially Equivalent |
| K873807 | AUTOTRANSFUSION APPARATUS | Mar 9, 1988 | Substantially Equivalent |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | Oct 23, 1987 | Substantially Equivalent |
| K870052 | INFUMIX MIXING CONTAINER | Feb 27, 1987 | Substantially Equivalent |
| K822716 | UNIVERSAL CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |
| K822715 | PLATELET CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |