FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCAREL AGAR MYCOBROTIC AGAR
K Number: K823308
·
Decision Dec 3, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- MYCAREL AGAR MYCOBROTIC AGAR
- K Number
- K823308
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Troy Biologicals, Inc.
- Date Received
- November 5, 1982
- Decision Date
- December 3, 1982
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSJ), ordered by most recent decision date.
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YM BROTH
FDA 510(k)
FDA Class 1
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MITIS SALIVARIUS AGAR
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W-L DIFFERENTIAL MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
LITTMAN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K823311 | COLUMBIA V AGAR W/5% HUMAN BLOOD | Dec 15, 1982 | Substantially Equivalent |
| K823309 | MARTIN & LEMIS AGAR W/VCAT INHIBITOR | Dec 3, 1982 | Substantially Equivalent |