FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
IDEIA(TM) ROTAVIRUS
K Number: K932384
·
Decision Dec 27, 1993
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
6
Review Days
224
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Basic Information
- Device Name
- IDEIA(TM) ROTAVIRUS
- K Number
- K932384
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dako Diagnostics , Ltd.
- Date Received
- May 17, 1993
- Decision Date
- December 27, 1993
- Product Code
- LIQ
- 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 |
|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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VIDAS ROTAVIRUS ASSAY
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ROTA-DAN RAPID ROTAVIRUS EIA KIT
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Other Clearances by Dako Diagnostics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K981226 | IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 | Sep 28, 1998 | Substantially Equivalent |
| K973954 | IMAGEN RESPIRATORY SCREEN | Dec 22, 1997 | Substantially Equivalent |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dec 26, 1996 | Substantially Equivalent |
| K940564 | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION | Jan 11, 1996 | Substantially Equivalent |
| K943557 | IMAGEN | Jan 9, 1995 | Substantially Equivalent |