FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIAGE PROTEIN C TEST
K Number: K062530
·
Decision Jan 29, 2007
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
46
Review Days
153
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Basic Information
- Device Name
- TRIAGE PROTEIN C TEST
- K Number
- K062530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosite Incorporated
- Date Received
- August 29, 2006
- Decision Date
- January 29, 2007
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by Biosite Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Jun 11, 2010 | Substantially Equivalent |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Apr 19, 2010 | Substantially Equivalent |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | Nov 13, 2009 | Substantially Equivalent |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Jun 6, 2008 | Substantially Equivalent |
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | Dec 7, 2007 | Substantially Equivalent |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | Mar 1, 2007 | Substantially Equivalent |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Jul 10, 2006 | Substantially Equivalent |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Jun 22, 2006 | Substantially Equivalent |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Jan 23, 2006 | Substantially Equivalent |
| K051787 | TRIAGE BNP TEST, MODEL 98000XR | Sep 22, 2005 | Substantially Equivalent |