FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPECTRAL'S 2 IN 1 (TNI-MYO)
K Number: K020950
·
Decision May 24, 2002
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
12
Review Days
60
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Basic Information
- Device Name
- SPECTRAL'S 2 IN 1 (TNI-MYO)
- K Number
- K020950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spectral Diagnostics, Inc.
- Date Received
- March 25, 2002
- Decision Date
- May 24, 2002
- Product Code
- MMI
- 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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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Other Clearances by Spectral Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Nov 30, 2006 | Substantially Equivalent |
| DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | Jun 16, 2003 | Unknown |
| K030057 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST | Mar 19, 2003 | Substantially Equivalent |
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | Sep 30, 2002 | Substantially Equivalent |
| K014105 | SPECTRAL'S TROPONIN I | Feb 1, 2002 | Substantially Equivalent |
| K992127 | CARDIOQUANT TROPONIN I TEST | Oct 4, 1999 | Substantially Equivalent |
| K991447 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLS | Jun 11, 1999 | Substantially Equivalent |
| K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST | Oct 7, 1998 | Substantially Equivalent |
| K981474 | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) | May 7, 1998 | Substantially Equivalent |
| K972687 | CARDIAC STATUS CONTROLS/TROPONIN I | Jul 28, 1997 | Substantially Equivalent |