FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CROATEST (R) RHEUMATOID DIAGNOSTIC
K Number: K904416
·
Decision Jun 24, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
4
Review Days
270
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Basic Information
- Device Name
- CROATEST (R) RHEUMATOID DIAGNOSTIC
- K Number
- K904416
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biotrax, Inc.
- Date Received
- September 27, 1990
- Decision Date
- June 24, 1991
- Product Code
- GTQ
- 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 |
|---|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | FDA class 1 | Microbiology |
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