FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERM-KIT
K Number: K852480
·
Decision Jul 9, 1985
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
9
Review Days
28
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Basic Information
- Device Name
- DERM-KIT
- K Number
- K852480
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Culture Kits, Inc.
- Date Received
- June 11, 1985
- Decision Date
- July 9, 1985
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Culture Kits, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911846 | URI-THREE(TM), MODIFICATION | Oct 4, 1991 | Substantially Equivalent |
| K854672 | CANDI-KIT TM | Jul 11, 1986 | Substantially Equivalent |
| K853488 | STAPH KIT | Aug 28, 1985 | Substantially Equivalent |
| K851225 | URINE DUO | Aug 13, 1985 | Substantially Equivalent |
| K852582 | GONI-KIT | Jul 12, 1985 | Substantially Equivalent |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | Apr 29, 1985 | Substantially Equivalent |
| K850765 | STREP-KIT | Apr 24, 1985 | Substantially Equivalent |
| K850998 | URI-KIT | Apr 1, 1985 | Substantially Equivalent |