FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLUMBIA V AGAR W/5% HUMAN BLOOD
K Number: K823311
·
Decision Dec 15, 1982
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
12
Review Days
40
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Basic Information
- Device Name
- COLUMBIA V AGAR W/5% HUMAN BLOOD
- K Number
- K823311
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Troy Biologicals, Inc.
- Date Received
- November 5, 1982
- Decision Date
- December 15, 1982
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Troy Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861301 | BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 | Apr 21, 1986 | Substantially Equivalent |
| K832861 | SABOURAUD DEXTROSE AGAR | Sep 26, 1983 | Substantially Equivalent |
| K832862 | TRANSGROW MEDIUM | Sep 26, 1983 | Substantially Equivalent |
| K832860 | SXT BLOOD AGAR | Sep 26, 1983 | Substantially Equivalent |
| K832863 | STREP ID QUAD | Sep 26, 1983 | Substantially Equivalent |
| K823307 | CAMPYLOBACTER SELECTIVE AGAR | Dec 15, 1982 | Substantially Equivalent |
| K823306 | HEMOPHILUS QUAD 10 PLATE | Dec 15, 1982 | Substantially Equivalent |
| K823310 | STREPTOCOCCUS SELECTIVE AGAR | Dec 15, 1982 | Substantially Equivalent |
| K823308 | MYCAREL AGAR MYCOBROTIC AGAR | Dec 3, 1982 | Substantially Equivalent |
| K823309 | MARTIN & LEMIS AGAR W/VCAT INHIBITOR | Dec 3, 1982 | Substantially Equivalent |