FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYBREX LIDOCAINE
K Number: K802131
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
16
Applicant Total
883
Review Days
57
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Basic Information
- Device Name
- CYBREX LIDOCAINE
- K Number
- K802131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3555
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 4, 1980
- Decision Date
- October 31, 1980
- Product Code
- KLR
- 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 |
|---|---|---|---|
| KLR | Enzyme Immunoassay, Lidocaine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLR), ordered by most recent decision date.
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EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
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COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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