FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
K Number: K933997
·
Decision Nov 22, 1993
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
9
Applicant Total
5
Review Days
97
Basic Information
- Device Name
- PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
- K Number
- K933997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ALEXON BIOMEDICAL, INC.
- Date Received
- August 17, 1993
- Decision Date
- November 22, 1993
- Product Code
- GMD
- 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 |
|---|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | FDA class 2 | Microbiology |
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Other Clearances by ALEXON BIOMEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K964864 | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY | Feb 4, 1997 | Substantially Equivalent |
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | Feb 9, 1996 | Substantially Equivalent |
| K936191 | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY | Nov 17, 1994 | Substantially Equivalent |
| K874849 | PROSPECT/GIARDIA | Jan 5, 1988 | Substantially Equivalent |