FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K Number: K974881
·
Decision Mar 20, 1998
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
9
Applicant Total
46
Review Days
80
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Basic Information
- Device Name
- TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
- K Number
- K974881
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biosite Incorporated
- Date Received
- December 30, 1997
- Decision Date
- March 20, 1998
- Product Code
- MCB
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| MCB | Antigen, C. Difficile | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCB), ordered by most recent decision date.
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CLEARVIEW C. DIFF A
FDA 510(k)
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MERITEC C. DIFFICILE CONTROLS
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Biosite Incorporated
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K062530 | TRIAGE PROTEIN C TEST | Jan 29, 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 |