FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K Number: K980528
·
Decision Mar 3, 1998
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
20
Review Days
20
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
- CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
- K Number
- K980528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chiron Diagnostics Corp.
- Date Received
- February 11, 1998
- Decision Date
- March 3, 1998
- 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 Chiron Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Aug 5, 1999 | Substantially Equivalent |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Jun 30, 1999 | Substantially Equivalent |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Jun 18, 1999 | Substantially Equivalent |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Oct 15, 1998 | Substantially Equivalent |
| K981478 | ACS:CENTAUR CEA | Aug 12, 1998 | Substantially Equivalent |
| K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY | Aug 12, 1998 | Substantially Equivalent |
| K981592 | ACS:CENTAUR AFP | Jul 7, 1998 | Substantially Equivalent |
| K974029 | ACS TOBRAMYCIN | Feb 12, 1998 | Substantially Equivalent |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | Dec 8, 1997 | Substantially Equivalent |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Aug 8, 1997 | Substantially Equivalent |