FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYGEIA RAPID STREP A TEST
K Number: K862133
·
Decision Jun 25, 1986
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- HYGEIA RAPID STREP A TEST
- K Number
- K862133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hygeia Sciences
- Date Received
- June 4, 1986
- Decision Date
- June 25, 1986
- 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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