FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
K Number: K882998
·
Decision Sep 7, 1988
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
2
Review Days
51
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Basic Information
- Device Name
- ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
- K Number
- K882998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Amtec Diagnostics International, Inc.
- Date Received
- July 18, 1988
- Decision Date
- September 7, 1988
- 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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Other Clearances by Amtec Diagnostics International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873064 | AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT | Nov 4, 1987 | Substantially Equivalent |