FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K Number: K972160
·
Decision Aug 1, 1997
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
125
Applicant Total
44
Review Days
53
Basic Information
- Device Name
- CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
- K Number
- K972160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TRINITY LABORATORIES, INC.
- Date Received
- June 9, 1997
- Decision Date
- August 1, 1997
- Product Code
- DCK
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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