FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LINEAR ENZMATIC URIC ACID SYSTEM
K Number: K831398
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
23
Review Days
40
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Basic Information
- Device Name
- LINEAR ENZMATIC URIC ACID SYSTEM
- K Number
- K831398
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler, Inc.
- Date Received
- April 29, 1983
- Decision Date
- June 8, 1983
- 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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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
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FDA Class 1
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Other Clearances by Simmler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Nov 29, 1989 | Substantially Equivalent |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Feb 11, 1988 | Substantially Equivalent |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | Jan 21, 1988 | Substantially Equivalent |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | Jan 7, 1988 | Substantially Equivalent |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | Dec 18, 1987 | Substantially Equivalent |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | Nov 25, 1987 | Substantially Equivalent |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | Oct 29, 1987 | Substantially Equivalent |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | Oct 28, 1987 | Substantially Equivalent |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | Oct 20, 1987 | Substantially Equivalent |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Oct 7, 1987 | Substantially Equivalent |