FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEZLIN DIAGNOSTIC REAGENT
K Number: K820578
·
Decision May 12, 1982
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
13
Applicant Total
2
Review Days
70
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Basic Information
- Device Name
- MEZLIN DIAGNOSTIC REAGENT
- K Number
- K820578
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Miles Pharmaceuticals
- Date Received
- March 3, 1982
- Decision Date
- May 12, 1982
- Product Code
- JTT
- 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 |
|---|---|---|---|
| JTT | Susceptibility Test Powders, Antimicrobial | FDA class 2 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by Miles Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K872081 | CIPRO (TM) DIAGNOSTIC POWDER | Jun 15, 1987 | Substantially Equivalent |