FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
K Number: K860923
·
Decision May 16, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
3
Review Days
66
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Basic Information
- Device Name
- EZ DETECT, 5 MINUTE STREP-A COLOR TEST
- K Number
- K860923
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Self Care Systems, Inc.
- Date Received
- March 11, 1986
- Decision Date
- May 16, 1986
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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