FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMOTOPHYTE TEST MEDIUM
K Number: K810181
·
Decision Feb 5, 1981
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
12
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DERMOTOPHYTE TEST MEDIUM
- K Number
- K810181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Troy Biologicals, Inc.
- Date Received
- January 22, 1981
- Decision Date
- February 5, 1981
- 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.
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421
FDA 510(k)
FDA Class 1
·Microbiology
INHIBITORY MOLD AGAR
FDA 510(k)
FDA Class 1
·Microbiology
YM BROTH
FDA 510(k)
FDA Class 1
·Microbiology
MITIS SALIVARIUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K823308 | MYCAREL AGAR MYCOBROTIC AGAR | Dec 3, 1982 | Substantially Equivalent |