FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMATOPHYTE TEST MEDIUM
K Number: K870637
·
Decision Apr 14, 1987
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
114
Review Days
60
Basic Information
- Device Name
- DERMATOPHYTE TEST MEDIUM
- K Number
- K870637
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- HARDY MEDIA
- Date Received
- February 13, 1987
- Decision Date
- April 14, 1987
- 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 |
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Other Clearances by HARDY MEDIA
| K Number | Device Name | ||
|---|---|---|---|
| K880126 | LAURYL TRYPTOSE BROTH | Mar 31, 1988 | Substantially Equivalent |
| K880122 | MIDDLEBROOK 7H9 BROTH | Mar 31, 1988 | Substantially Equivalent |
| K880131 | LOWENSTEIN-JENSEN, GRUFT | Mar 31, 1988 | Substantially Equivalent |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | Mar 31, 1988 | Substantially Equivalent |
| K880120 | MOELLERS DECARBOXYLASE, LYSINE | Mar 31, 1988 | Substantially Equivalent |
| K880125 | LOWENSTEIN-JENSEN, SELECTIVE | Mar 31, 1988 | Substantially Equivalent |
| K880119 | MOELLERS DECARBOXYLASE, ONITHINE | Mar 31, 1988 | Substantially Equivalent |
| K880116 | MRVP BROTH | Mar 31, 1988 | Substantially Equivalent |
| K880121 | MOELLERS DECARBOXYLASE, BASE | Mar 31, 1988 | Substantially Equivalent |
| K880134 | MIDDLEBROOK 7H11 AGAR | Mar 31, 1988 | Substantially Equivalent |