FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHADEBACT MONOCLONAL GC TEST
K Number: K850351
·
Decision Mar 13, 1985
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
129
Review Days
44
Basic Information
- Device Name
- PHADEBACT MONOCLONAL GC TEST
- K Number
- K850351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- PHARMACIA, INC.
- Date Received
- January 28, 1985
- Decision Date
- March 13, 1985
- Product Code
- LIC
- 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 |
|---|---|---|---|
| LIC | Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Apr 23, 1997 | Substantially Equivalent |
| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |