FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOFLUOR CARBAMAZEPINE REAGENT SET
K Number: K893507
·
Decision Aug 11, 1989
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
55
Applicant Total
28
Review Days
98
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Basic Information
- Device Name
- INNOFLUOR CARBAMAZEPINE REAGENT SET
- K Number
- K893507
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Innotron of Oregon, Inc.
- Date Received
- May 5, 1989
- Decision Date
- August 11, 1989
- Product Code
- KLT
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| 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
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONLINE TDM CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Innotron of Oregon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET | Aug 22, 1990 | Substantially Equivalent |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Aug 9, 1990 | Substantially Equivalent |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | Apr 20, 1990 | Substantially Equivalent |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | Apr 19, 1990 | Substantially Equivalent |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | Apr 12, 1990 | Substantially Equivalent |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | Apr 12, 1990 | Substantially Equivalent |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent |
| K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | Oct 31, 1989 | Substantially Equivalent |