FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KALLESTAD RSV MICROPLATE EIA
K Number: K924289
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
1
Applicant Total
82
Review Days
175
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Basic Information
- Device Name
- KALLESTAD RSV MICROPLATE EIA
- K Number
- K924289
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories, Inc.
- Date Received
- August 21, 1992
- Decision Date
- February 12, 1993
- Product Code
- MCE
- 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 |
|---|---|---|---|
| MCE | Respiratory Syncytial Virus - Elisa | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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