FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K Number: K965213
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
45
Applicant Total
30
Review Days
42
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Basic Information
- Device Name
- STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
- K Number
- K965213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Intl., Inc.
- Date Received
- December 30, 1996
- Decision Date
- February 10, 1997
- Product Code
- DDR
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Dade Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974343 | DADE INNOVIN | Jul 22, 1998 | Substantially Equivalent |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | Nov 17, 1997 | Substantially Equivalent |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Nov 6, 1997 | Substantially Equivalent |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | Oct 20, 1997 | Substantially Equivalent |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Sep 8, 1997 | Substantially Equivalent |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Aug 15, 1997 | Substantially Equivalent |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | Jul 7, 1997 | Substantially Equivalent |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Jun 4, 1997 | Substantially Equivalent |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | May 2, 1997 | Substantially Equivalent |
| K964715 | PARAMAX SALICYLATE REAGENT | Apr 25, 1997 | Substantially Equivalent |