FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESERV MF FIXATIVE 15ML
K Number: K840086
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
18
Review Days
20
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Basic Information
- Device Name
- PRESERV MF FIXATIVE 15ML
- K Number
- K840086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Preventive Diagnostics Corp.
- Date Received
- January 10, 1984
- Decision Date
- January 30, 1984
- Product Code
- LIO
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
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Other Clearances by Preventive Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K840677 | HDL EZ-TZ3 CHOLESTEROL REAGENT KIT | Apr 13, 1984 | Substantially Equivalent |
| K840676 | PDC HDL EZ-SEP CHOLESTEROL REAGENT | Apr 4, 1984 | Substantially Equivalent |
| K840218 | TRIGLYCERIDE AQUEOUS STANDARDS | Mar 23, 1984 | Substantially Equivalent |
| K840278 | HDL CHOLESTEROL CONTROLS-LEVELS | Mar 23, 1984 | Substantially Equivalent |
| K840990 | PRESERV CARY BLAIR TRANSPORT PACK | Mar 23, 1984 | Substantially Equivalent |
| K840220 | HDL CHOLESTEROL AQUEOUS STANDARDS | Mar 23, 1984 | Substantially Equivalent |
| K840189 | TOTAL CHOLESTEROL REAGENT SET | Mar 23, 1984 | Substantially Equivalent |
| K840219 | TRIGLYCERIDE/CHOLESTEROL AQUEOUS | Mar 23, 1984 | Substantially Equivalent |
| K840991 | PRESERV BUFFERED GLYCEROL SALINE | Mar 23, 1984 | Substantially Equivalent |
| K840968 | PRESERV TRANSPORT & CULTURE PACK | Mar 23, 1984 | Substantially Equivalent |