FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHARMACIA B2-MICRO RIA
K Number: K842772
·
Decision Nov 1, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
10
Applicant Total
129
Review Days
108
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Basic Information
- Device Name
- PHARMACIA B2-MICRO RIA
- K Number
- K842772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- July 16, 1984
- Decision Date
- November 1, 1984
- Product Code
- JGZ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JGZ | O-Phthalaldehyde, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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Other Clearances by Pharmacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Feb 9, 1998 | Substantially Equivalent |
| K972364 | UNICAP PHADIATOP | Sep 4, 1997 | Substantially Equivalent |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | Jul 3, 1997 | Substantially Equivalent |
| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | Jun 30, 1997 | Substantially Equivalent |
| 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 |