FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACON STREP A RAPID TEST DEVICE
K Number: K031784
·
Decision Jul 14, 2003
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
85
Review Days
34
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Basic Information
- Device Name
- ACON STREP A RAPID TEST DEVICE
- K Number
- K031784
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ACON Laboratories, Inc.
- Date Received
- June 10, 2003
- Decision Date
- July 14, 2003
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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