FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROSPECT MICROPLATE ASSAY
K Number: K934493
·
Decision Sep 20, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
10
Review Days
370
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Basic Information
- Device Name
- PROSPECT MICROPLATE ASSAY
- K Number
- K934493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alexon, Inc.
- Date Received
- September 15, 1993
- Decision Date
- September 20, 1994
- Product Code
- LLH
- 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLH), ordered by most recent decision date.
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OSOM C. DIFFICILE TOXIN A/B TEST
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PROGASTRO CD ASSAY
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C. DIFF QUIK CHEK COMPLETE
FDA 510(k)
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BD GENEOHM CDIFF ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Alexon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942098 | PROSPECT GIARDIA | Sep 9, 1994 | Substantially Equivalent |
| K931147 | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION | May 13, 1993 | Substantially Equivalent |
| K930451 | PROSPEC T GIARDIA MICROTITER ASSAY | Apr 21, 1993 | Substantially Equivalent |
| K922675 | PROSPECT GIARDIA CONTROLS | Sep 11, 1992 | Substantially Equivalent |
| K922010 | PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION | Jun 19, 1992 | Substantially Equivalent |
| K920817 | MODIFICATION PROSPECT GIARDIA RAPID ASSAY | Apr 22, 1992 | Substantially Equivalent |
| K912242 | PROSPECT(TM/CRYPTOSPORIDIUM | Mar 23, 1992 | Substantially Equivalent |
| K915093 | PROSPECT(TM) GIARDIA RAPID ASSAY | Jan 30, 1992 | Substantially Equivalent |
| K911337 | PROSPEC T/GIARDIA RAPID ASSAY | Sep 27, 1991 | Substantially Equivalent |