FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K Number: K033479
·
Decision Feb 26, 2004
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
17
Review Days
115
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Basic Information
- Device Name
- PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
- K Number
- K033479
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remel, Inc.
- Date Received
- November 3, 2003
- Decision Date
- February 26, 2004
- 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 |
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| K981391 | PAR-ONE | Jul 14, 1998 | Substantially Equivalent |