FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESERV PVA FIXATIVE -MALIN PACK
K Number: K833660
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
11
Applicant Total
18
Review Days
41
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Basic Information
- Device Name
- PRESERV PVA FIXATIVE -MALIN PACK
- K Number
- K833660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Preventive Diagnostics Corp.
- Date Received
- October 18, 1983
- Decision Date
- November 28, 1983
- Product Code
- KDT
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | FDA class 1 | Pathology |
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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 |