FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K Number: K022538
·
Decision Aug 23, 2002
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
37
Applicant Total
77
Review Days
22
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Basic Information
- Device Name
- IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
- K Number
- K022538
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1645
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Date Received
- August 1, 2002
- Decision Date
- August 23, 2002
- Product Code
- JIR
- 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 |
|---|---|---|---|
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Diagnostic Chemicals, Ltd. (Usa)
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K901510 | ENZYMATIC THEOPHYLLINE REAGENT, #500-82 | Jun 12, 1990 | Substantially Equivalent |