FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC STATUS TROPONIN I
K Number: K963513
·
Decision Nov 7, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
91
Applicant Total
70
Review Days
65
Basic Information
- Device Name
- CARDIAC STATUS TROPONIN I
- K Number
- K963513
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PRINCETON BIOMEDITECH CORP.
- Date Received
- September 3, 1996
- Decision Date
- November 7, 1996
- 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.
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
PATHFAST®hs-cTnI-II
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
Other Clearances by PRINCETON BIOMEDITECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K130650 | STATUS DS OXY | Feb 26, 2014 | Substantially Equivalent |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Dec 10, 2013 | Substantially Equivalent |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Sep 9, 2013 | Substantially Equivalent |
| K083746 | BIOSIGN FLU A+B | Nov 10, 2010 | Substantially Equivalent |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Jul 1, 2010 | Substantially Equivalent |
| K100341 | SPERMCHECK FERTILITY | May 4, 2010 | Substantially Equivalent |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Oct 6, 2008 | Substantially Equivalent |
| K073039 | SPERMCHECK VASECTOMY | Jan 24, 2008 | Substantially Equivalent |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | Nov 26, 2007 | Substantially Equivalent |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | Feb 20, 2007 | Substantially Equivalent |