FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇽 Mexico
SALMONELLA IFA*
K Number: K885114
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
0
Applicant Total
24
Review Days
246
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Basic Information
- Device Name
- SALMONELLA IFA*
- K Number
- K885114
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Investigacion Farmaceutica S.A. DE C.V.
- Date Received
- December 12, 1988
- Decision Date
- August 15, 1989
- Product Code
- GHC
- 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 |
|---|---|---|---|
| GHC | Tube, Sedimentation Rate | FDA class 1 | Hematology |
Other Clearances by Investigacion Farmaceutica S.A. DE C.V.
| K Number | Device Name | ||
|---|---|---|---|
| K892721 | IFA SENSIBAC CEFACLOR | Nov 30, 1989 | Substantially Equivalent |
| K892728 | IFA SENSIBAC NORFLOXACIN | Sep 21, 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 |