FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
K Number: K951890
·
Decision Jul 13, 1995
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
30
Review Days
80
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
- K Number
- K951890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Intl., Inc.
- Date Received
- April 24, 1995
- Decision Date
- July 13, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMI), ordered by most recent decision date.
i-STAT hs-TnI cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access hsTnI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access hsTnI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT hs-TnI cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® IM High-Sensitivity Troponin I (TnIH)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |