FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INNOFLUOR TOPIRAMATE CONTROL SET
K Number: K970517
·
Decision May 12, 1997
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- INNOFLUOR TOPIRAMATE CONTROL SET
- K Number
- K970517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oxis Intl., Inc.
- Date Received
- February 11, 1997
- Decision Date
- May 12, 1997
- Product Code
- LAS
- 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
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Other Clearances by Oxis Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972331 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Aug 1, 1997 | Substantially Equivalent |
| K972330 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM | Jul 14, 1997 | Substantially Equivalent |
| K970510 | INNOFLOUR TOPIRAMATE REAGENT SET | May 12, 1997 | Substantially Equivalent |
| K970509 | INNOFLOUR CALIBRATOR REAGENT SET | May 12, 1997 | Substantially Equivalent |
| K955568 | INNOFLUOR QUINIDINE ASSAY SYSTEM | Apr 4, 1996 | Substantially Equivalent |
| K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K955569 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K955562 | INNOFLUOR PHENYTOIN ASSAY SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K950346 | B-L RED(TM) DISCS | May 5, 1995 | Substantially Equivalent |