FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MACLEAN-FOGG, DISPOS-INOCULA-LOOPS
K Number: K842057
·
Decision Jun 7, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
23
Review Days
16
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Basic Information
- Device Name
- MACLEAN-FOGG, DISPOS-INOCULA-LOOPS
- K Number
- K842057
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Polymer Technology Corp.
- Date Received
- May 22, 1984
- Decision Date
- June 7, 1984
- Product Code
- LIB
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | FDA class 1 | Microbiology |
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