FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K Number: K964152
·
Decision Apr 23, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
129
Review Days
189
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
- K Number
- K964152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pharmacia, Inc.
- Date Received
- October 16, 1996
- Decision Date
- April 23, 1997
- Product Code
- DGC
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DGC), ordered by most recent decision date.
Kenota 1 Total IgE; Kenota 1 (instrument)
FDA 510(k)
FDA Class 2
·Immunology
Quantia IgE
FDA 510(k)
FDA Class 2
·Immunology
Total Immunoglobulin E (IgE)
FDA 510(k)
FDA Class 2
·Immunology
ADVIA Centaur Total IgE (tIgE)
FDA 510(k)
FDA Class 2
·Immunology
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
FDA 510(k)
FDA Class 2
·Immunology
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 |
| 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 |
| K911903 | ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA | Aug 12, 1991 | Substantially Equivalent |