FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM(TM) QUINIDINE
K Number: K940682
·
Decision Jun 21, 1994
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
883
Review Days
131
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Basic Information
- Device Name
- AXSYM(TM) QUINIDINE
- K Number
- K940682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- February 10, 1994
- Decision Date
- June 21, 1994
- Product Code
- LGI
- 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 |
|---|---|---|---|
| LGI | Fluorescence Polarization Immunoassay, Carbamazepine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGI), ordered by most recent decision date.
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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