FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.
K Number: K810427
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
327
Applicant Total
6
Review Days
41
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Basic Information
- Device Name
- CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.
- K Number
- K810427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pfizer Pharmaceuticals
- Date Received
- February 18, 1981
- Decision Date
- March 31, 1981
- 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 Pfizer Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K885321 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Mar 22, 1989 | Substantially Equivalent for Some Indications |
| K802408 | E-VAC BLOOD CULTURE SYSTEM | Oct 23, 1980 | Substantially Equivalent |
| K771605 | CREATINE KINASE ISOENZYME SUBSTRATE SET | Sep 15, 1977 | Substantially Equivalent |
| K770801 | MICROBIO. PROD. FLUORESCENT ANTIBODY | May 25, 1977 | Substantially Equivalent |
| K770425 | NEEDLES, STERILE, AIRWAY | Apr 15, 1977 | Substantially Equivalent |