FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ZYME A
K Number: K820208
·
Decision Feb 5, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
23
Review Days
10
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Basic Information
- Device Name
- ZYME A
- K Number
- K820208
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Dms Laboratories
- Date Received
- January 26, 1982
- Decision Date
- February 5, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
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 |
| K820209 | ZYME B | Feb 12, 1982 | Substantially Equivalent |
| K820212 | OXI | Feb 12, 1982 | Substantially Equivalent |