FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM SALICYLATE
K Number: K951290
·
Decision Aug 8, 1995
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
28
Applicant Total
883
Review Days
140
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Basic Information
- Device Name
- AXSYM SALICYLATE
- K Number
- K951290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3830
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- March 21, 1995
- Decision Date
- August 8, 1995
- Product Code
- DKJ
- 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 |
|---|---|---|---|
| DKJ | Colorimetry, Salicylate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKJ), ordered by most recent decision date.
ADVIA CHEMISTRY SALICYLATE REAGENT
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EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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