FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D
K Number: K812916
·
Decision Nov 6, 1981
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
322
Applicant Total
39
Review Days
18
Basic Information
- Device Name
- MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D
- K Number
- K812916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- GENERAL DIAGNOSTICS
- Date Received
- October 19, 1981
- Decision Date
- November 6, 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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| K Number | Device Name | ||
|---|---|---|---|
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| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | Jul 20, 1984 | Substantially Equivalent |
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | Jul 2, 1984 | Substantially Equivalent |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | Dec 30, 1983 | Substantially Equivalent |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | Oct 14, 1983 | Substantially Equivalent |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | May 9, 1983 | Substantially Equivalent |