FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIQUI-HEME GLYCO A1C ASSAY
K Number: K031296
·
Decision Oct 15, 2004
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
11
Review Days
541
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Basic Information
- Device Name
- LIQUI-HEME GLYCO A1C ASSAY
- K Number
- K031296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biodiagnostic Intl
- Date Received
- April 23, 2003
- Decision Date
- October 15, 2004
- Product Code
- LCP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Biodiagnostic Intl
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|---|---|---|---|
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| 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 |
| K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS | Apr 4, 1984 | 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 |