FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇽 Mexico
IFA SENSIBAC NORFLOXACIN
K Number: K892728
·
Decision Sep 21, 1989
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
327
Applicant Total
24
Review Days
160
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Basic Information
- Device Name
- IFA SENSIBAC NORFLOXACIN
- K Number
- K892728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Investigacion Farmaceutica S.A. DE C.V.
- Date Received
- April 14, 1989
- Decision Date
- September 21, 1989
- Product Code
- JTN
- 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | FDA class 2 | Microbiology |
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Other Clearances by Investigacion Farmaceutica S.A. DE C.V.
| K Number | Device Name | ||
|---|---|---|---|
| K892721 | IFA SENSIBAC CEFACLOR | Nov 30, 1989 | Substantially Equivalent |
| K892733 | IFA SENSIBAC KANAMYCIN | Aug 17, 1989 | Substantially Equivalent |
| K892713 | IFA SENSIBAC NALIDIXIC ACID | Aug 17, 1989 | Substantially Equivalent |
| K892735 | IFA SENSIBAC CEPHALOTIN | Aug 17, 1989 | Substantially Equivalent |
| K892726 | IFA SENSIBAC PENICILLIN | Aug 15, 1989 | Substantially Equivalent |
| K885112 | BRUCELLA IFA* | Aug 15, 1989 | Substantially Equivalent |
| K892720 | IFA SENSIBAC GENTAMYCIN | Aug 15, 1989 | Substantially Equivalent |
| K885113 | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL | Aug 15, 1989 | Substantially Equivalent |
| K885110 | PROTEUS OX-19 IFA* | Aug 15, 1989 | Substantially Equivalent |
| K885114 | SALMONELLA IFA* | Aug 15, 1989 | Substantially Equivalent |