FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAM NEGATIVE BACTERIAL IDENTIF- PANELS
K Number: K823738
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
7
Review Days
25
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Basic Information
- Device Name
- GRAM NEGATIVE BACTERIAL IDENTIF- PANELS
- K Number
- K823738
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Micro-Media Systems, Inc.
- Date Received
- December 13, 1982
- Decision Date
- January 7, 1983
- 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 Micro-Media Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953422 | FOX FASTIDIOUS TEST PANELS | Oct 7, 1995 | Substantially Equivalent |
| K945997 | MODIFIED FOX EXTRA GRAM POSITIVE | Feb 16, 1995 | Substantially Equivalent |
| K801547 | TEST PANEL FOR PRESUMP. ID/BACT. ORG | Sep 9, 1980 | Substantially Equivalent |
| K791991 | STREP-SPEC | Nov 13, 1979 | Substantially Equivalent |
| K770745 | PANEL, GNF, MICRO-ID | Jun 23, 1977 | Substantially Equivalent |
| K770746 | PANEL, IDENTIFICATION, STREP, MICRO-ID | Jun 23, 1977 | Substantially Equivalent |