FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS CARBAMAZEPINE TEST SYSTEM
K Number: K896860
·
Decision Jan 2, 1990
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
35
Review Days
28
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Basic Information
- Device Name
- OPUS CARBAMAZEPINE TEST SYSTEM
- K Number
- K896860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Pb Diagnostic Systems, Inc.
- Date Received
- December 5, 1989
- Decision Date
- January 2, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLT), ordered by most recent decision date.
Carbamazepine Gen 4
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FDA Class 2
·Clinical Toxicology
ABBOTT CARBAMAZEPINE ASSAY
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FDA Class 2
·Clinical Toxicology
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVIA IMS CARBAMAZEPINE METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONLINE TDM CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Pb Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | Jul 28, 1994 | Substantially Equivalent |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | Jul 20, 1994 | Substantially Equivalent |
| K933389 | OPUS CMV-G | Jun 28, 1994 | Substantially Equivalent |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Mar 7, 1994 | Substantially Equivalent |
| K935229 | OPUS DIGITOXIN | Dec 22, 1993 | Substantially Equivalent |
| K934705 | OPUS NAPA | Nov 22, 1993 | Substantially Equivalent |
| K933675 | OPUS TOTAL CK | Sep 8, 1993 | Substantially Equivalent |
| K933066 | OPUS ESTRADIOL | Sep 8, 1993 | Substantially Equivalent |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | Jul 8, 1993 | Substantially Equivalent |
| K926131 | OPUS MAGNUM ANALYZER | Jun 7, 1993 | Substantially Equivalent |