FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K Number: K964765
·
Decision Feb 14, 1997
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
20
Review Days
79
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Basic Information
- Device Name
- CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
- K Number
- K964765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Diagnostics Corp.
- Date Received
- November 27, 1996
- Decision Date
- February 14, 1997
- Product Code
- KLT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KLT | Enzyme Immunoassay, Carbamazepine | FDA class 2 | Clinical Toxicology |
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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 |
| K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | Mar 3, 1998 | Substantially Equivalent |
| K974029 | ACS TOBRAMYCIN | Feb 12, 1998 | Substantially Equivalent |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | Dec 8, 1997 | Substantially Equivalent |