FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K Number: K873282
·
Decision Sep 22, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
19
Review Days
36
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Basic Information
- Device Name
- CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
- K Number
- K873282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Windsor Laboratories, Inc.
- Date Received
- August 17, 1987
- Decision Date
- September 22, 1987
- 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.
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ABBOTT CARBAMAZEPINE ASSAY
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ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
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CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
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ADVIA IMS CARBAMAZEPINE METHOD
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FDA Class 2
·Clinical Toxicology
ONLINE TDM CARBAMAZEPINE
FDA 510(k)
FDA Class 2
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Other Clearances by Windsor Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT | Oct 28, 1987 | Substantially Equivalent |
| K871486 | (FPIA) ASSAY BUFFER | May 8, 1987 | Substantially Equivalent |
| K870389 | DIGOXIN (FPIA) CALIBRATOR KIT | Apr 1, 1987 | Substantially Equivalent |
| K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT | Apr 1, 1987 | Substantially Equivalent |
| K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY | Jan 5, 1987 | Substantially Equivalent |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | Nov 10, 1986 | Substantially Equivalent |
| K863244 | AMIKACIN (FPIA) CALIBRATOR KIT | Aug 29, 1986 | Substantially Equivalent |
| K862248 | AMIKACIN KIT (FPIA) | Aug 4, 1986 | Substantially Equivalent |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |