FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELECT-A-FLOW
K Number: K811857
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
2
Review Days
9
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Basic Information
- Device Name
- SELECT-A-FLOW
- K Number
- K811857
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wenmar Intl. Corp.
- Date Received
- July 1, 1981
- Decision Date
- July 10, 1981
- 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.
URIC ACID MODEL 3P39
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OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
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VITALAB URIC ACID REAGENT
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ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
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URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
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Other Clearances by Wenmar Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K810645 | SELECT-A-FLOW COLLECTOR | May 5, 1981 | Substantially Equivalent |