FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARA-PAK FORMALIN
K Number: K792705
·
Decision Jan 21, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
6
Applicant Total
92
Review Days
25
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Basic Information
- Device Name
- PARA-PAK FORMALIN
- K Number
- K792705
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Meridian Diagnostics, Inc.
- Date Received
- December 27, 1979
- Decision Date
- January 21, 1980
- Product Code
- IGG
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| IGG | Formaldehyde (Formalin, Formol) | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IGG), ordered by most recent decision date.
ZINC FORMALIN CONCENTRATE
FDA 510(k)
FDA Class 1
·Pathology
FORMALDEHYDE SOLUTION, 37%
FDA 510(k)
FDA Class 1
·Pathology
37% FORMALDEHYDE
FDA 510(k)
FDA Class 1
·Pathology
PLEASCENT OR FORMA-SCENT
FDA 510(k)
FDA Class 1
·Pathology
PARA-PAK SAF
FDA 510(k)
FDA Class 1
·Pathology
FORMALIN BUFFER CONCENTRATE
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Meridian Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Dec 10, 1999 | Substantially Equivalent |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Aug 9, 1999 | Substantially Equivalent |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| 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 |