FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
K Number: DEN030002
·
Decision Jun 16, 2003
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
12
Review Days
63
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Basic Information
- Device Name
- ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
- K Number
- DEN030002
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.3210
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Spectral Diagnostics, Inc.
- Date Received
- April 14, 2003
- Decision Date
- June 16, 2003
- Product Code
- NGS
- 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 |
|---|---|---|---|
| NGS | Assay, Endotoxin Activity, Chemiluminescent | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NGS), ordered by most recent decision date.
View allOther Clearances by Spectral Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Nov 30, 2006 | Substantially Equivalent |
| 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 |
| K020950 | SPECTRAL'S 2 IN 1 (TNI-MYO) | May 24, 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 |