FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
K Number: K964144
·
Decision Nov 27, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
5
Review Days
41
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Basic Information
- Device Name
- PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
- K Number
- K964144
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Para Scientific Co.
- Date Received
- October 17, 1996
- Decision Date
- November 27, 1996
- 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 Para Scientific Co.
| K Number | Device Name | ||
|---|---|---|---|
| K021420 | PARACON II/FECAL CONCENTRATOR II | Jun 4, 2002 | Substantially Equivalent |
| K881649 | MODIFIED PARACON(TM) CONCENTRATION KIT | Apr 21, 1988 | Substantially Equivalent |
| K872751 | FLUORTRAN - C(TM) | Jul 23, 1987 | Substantially Equivalent |
| K853715 | PARA CON TM | Oct 2, 1985 | Substantially Equivalent |