FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
B-L RED(TM) DISCS
K Number: K950346
·
Decision May 5, 1995
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
11
Review Days
98
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Basic Information
- Device Name
- B-L RED(TM) DISCS
- K Number
- K950346
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oxis Intl., Inc.
- Date Received
- January 27, 1995
- Decision Date
- May 5, 1995
- Product Code
- JTO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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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 |
| K970517 | INNOFLUOR TOPIRAMATE CONTROL 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 |