FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHADEBACT SHIGELLA TEST
K Number: K880752
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
40
Applicant Total
129
Review Days
359
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Basic Information
- Device Name
- PHADEBACT SHIGELLA TEST
- K Number
- K880752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- February 24, 1988
- Decision Date
- February 17, 1989
- Product Code
- GNB
- 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 |
|---|---|---|---|
| GNB | Antisera, All Types, Shigella Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNB), ordered by most recent decision date.
SAS SHIGELLA SONNEI FORM II ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
FDA 510(k)
FDA Class 2
·Microbiology
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
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 |