FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARA-PAK CLEAN VIAL
K Number: K792710
·
Decision Jan 28, 1980
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
92
Review Days
32
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Basic Information
- Device Name
- PARA-PAK CLEAN VIAL
- K Number
- K792710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Meridian Diagnostics, Inc.
- Date Received
- December 27, 1979
- Decision Date
- January 28, 1980
- Product Code
- FMH
- Advisory Committee
- Pathology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
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|---|---|---|---|
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| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | Dec 17, 1998 | Substantially Equivalent |
| K982764 | PREMIER CRYPTOSPORIDIUM | Dec 3, 1998 | Substantially Equivalent |
| K982711 | PREMIER GIARDIA | Nov 25, 1998 | Substantially Equivalent |
| K980076 | PREMIER PLATINUM HPSA | May 12, 1998 | Substantially Equivalent |
| K980077 | PARA-PAK SPINCON | Apr 2, 1998 | Substantially Equivalent |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Aug 20, 1997 | Substantially Equivalent |