FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID ASSAY KIT
K Number: K842246
·
Decision Jul 18, 1984
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
77
Review Days
43
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Basic Information
- Device Name
- URIC ACID ASSAY KIT
- K Number
- K842246
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Date Received
- June 5, 1984
- Decision Date
- July 18, 1984
- 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 |
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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
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Other Clearances by Diagnostic Chemicals, Ltd. (Usa)
| K Number | Device Name | ||
|---|---|---|---|
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | Aug 23, 2002 | Substantially Equivalent |
| K974874 | BILIRUBIN-SL (TOTAL) ASSAY | Feb 12, 1998 | Substantially Equivalent |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Aug 2, 1994 | Substantially Equivalent |
| K932766 | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) | Dec 10, 1993 | Substantially Equivalent |
| K932555 | DC-LINEATE CAT. NO. SE-091 | Aug 19, 1993 | Substantially Equivalent |
| K925877 | DC-UIBC-CAL | Mar 18, 1993 | Substantially Equivalent |
| K912825 | MAGNESIUM ASSAY KIT, CAT.# 100-12 | Jul 26, 1991 | Substantially Equivalent |
| K895964 | DCL SYPHILIS-M CATALOG NO. 600-80 | Jan 8, 1991 | Substantially Equivalent |
| K895965 | DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 | Dec 26, 1990 | Substantially Equivalent |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Nov 20, 1990 | Substantially Equivalent |