FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K Number: K082661
·
Decision Oct 6, 2008
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
72
Review Days
24
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Basic Information
- Device Name
- BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
- K Number
- K082661
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- September 12, 2008
- Decision Date
- October 6, 2008
- 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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