FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID NFT
K Number: K831186
·
Decision May 9, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
12
Applicant Total
23
Review Days
27
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Basic Information
- Device Name
- RAPID NFT
- K Number
- K831186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dms Laboratories
- Date Received
- April 12, 1983
- Decision Date
- May 9, 1983
- Product Code
- JSN
- 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 |
|---|---|---|---|
| JSN | Culture Media, Propagating Transport | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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AMIES TRANSPORT MEDIUM W/O CHARCOAL
FDA 510(k)
FDA Class 1
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Other Clearances by Dms Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K831187 | TRP | May 9, 1983 | Substantially Equivalent |
| K830437 | CHS | Mar 17, 1983 | Substantially Equivalent |
| K823102 | AGAR P | Dec 3, 1982 | Substantially Equivalent |
| K821038 | FAST VIOLET B | May 27, 1982 | Substantially Equivalent |
| K813612 | RAPID ZYME | Feb 22, 1982 | Substantially Equivalent |
| K813613 | RAPID CH | Feb 22, 1982 | Substantially Equivalent |
| K820213 | SALINE SOLUTION | Feb 12, 1982 | Substantially Equivalent |
| K820209 | ZYME B | Feb 12, 1982 | Substantially Equivalent |
| K820212 | OXI | Feb 12, 1982 | Substantially Equivalent |
| K820210 | IND | Feb 12, 1982 | Substantially Equivalent |