FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FAST VIOLET B
K Number: K821038
·
Decision May 27, 1982
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
23
Review Days
44
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Basic Information
- Device Name
- FAST VIOLET B
- K Number
- K821038
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Dms Laboratories
- Date Received
- April 13, 1982
- Decision Date
- May 27, 1982
- Product Code
- JTS
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | FDA class 1 | Hematology |
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Other Clearances by Dms Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K831186 | RAPID NFT | May 9, 1983 | Substantially Equivalent |
| K831187 | TRP | May 9, 1983 | Substantially Equivalent |
| K830437 | CHS | Mar 17, 1983 | Substantially Equivalent |
| K823102 | AGAR P | Dec 3, 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 |