FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
K Number: K974461
·
Decision Dec 10, 1997
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
46
Review Days
15
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Basic Information
- Device Name
- TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
- K Number
- K974461
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biosite Incorporated
- Date Received
- November 25, 1997
- Decision Date
- December 10, 1997
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |