FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INNOFLUOR PRIMIDONE
K Number: K844721
·
Decision Jan 8, 1985
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
22
Applicant Total
6
Review Days
35
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Basic Information
- Device Name
- INNOFLUOR PRIMIDONE
- K Number
- K844721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Innotron Diagnostics
- Date Received
- December 4, 1984
- Decision Date
- January 8, 1985
- Product Code
- LKT
- Advisory Committee
- Microbiology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | FDA class 1 | Microbiology |
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Other Clearances by Innotron Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K850629 | INNOFLUOR THEOPHYLLINE | Mar 12, 1985 | Substantially Equivalent |
| K841865 | INNOFLOUR GENTAMICIN | May 31, 1984 | Substantially Equivalent |
| K841866 | INNOFLOUR TOBRAMYCIN | May 31, 1984 | Substantially Equivalent |
| K841707 | INNOFLUOR PHENOBARBITAL | May 23, 1984 | Substantially Equivalent |
| K841706 | INNOFLUOR PHENYTOIN | May 22, 1984 | Substantially Equivalent |