FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUI-URA CHEMISTRY URINE CONTROLS
K Number: K840618
·
Decision Apr 4, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
11
Review Days
50
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Basic Information
- Device Name
- LIQUI-URA CHEMISTRY URINE CONTROLS
- K Number
- K840618
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodiagnostic Intl
- Date Received
- February 14, 1984
- Decision Date
- April 4, 1984
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Biodiagnostic Intl
| K Number | Device Name | ||
|---|---|---|---|
| K031296 | LIQUI-HEME GLYCO A1C ASSAY | Oct 15, 2004 | Substantially Equivalent |
| K881430 | LIQUI-SERA SERUM ALCOHOL CONTROLS | Jul 8, 1988 | Substantially Equivalent |
| K874459 | LIQUI-SERA SPINAL FLUID CONTROL | Dec 29, 1987 | Substantially Equivalent |
| K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS | Nov 24, 1986 | Substantially Equivalent |
| K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) | Oct 4, 1985 | Substantially Equivalent |
| K853887 | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS | Sep 30, 1985 | Substantially Equivalent |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Mar 5, 1985 | Substantially Equivalent |
| K834398 | LIQUI-SERA TDM CALIBRATORS | Feb 3, 1984 | Substantially Equivalent |
| K834259 | LIQUI-URA TOXIC URINE CONTROL | Jan 30, 1984 | Substantially Equivalent |
| K831278 | LIQUI-SERA ANTICONVULSANTS CONTROLS | May 27, 1983 | Substantially Equivalent |