FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZYME B
K Number: K820209
·
Decision Feb 12, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
23
Review Days
17
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Basic Information
- Device Name
- ZYME B
- K Number
- K820209
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dms Laboratories
- Date Received
- January 26, 1982
- Decision Date
- February 12, 1982
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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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 |
| 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 |
| K820212 | OXI | Feb 12, 1982 | Substantially Equivalent |
| K820210 | IND | Feb 12, 1982 | Substantially Equivalent |