FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BI-CRP LATEX TEST
K Number: K811374
·
Decision Jun 12, 1981
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
9
Review Days
28
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Basic Information
- Device Name
- BI-CRP LATEX TEST
- K Number
- K811374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Biologics Intl., Inc.
- Date Received
- May 15, 1981
- Decision Date
- June 12, 1981
- Product Code
- DCN
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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Other Clearances by Biologics Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882229 | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS | Aug 16, 1988 | Substantially Equivalent |
| K823353 | CARCINO-CEK | Dec 14, 1982 | Substantially Equivalent |
| K812060 | BI-ASO SLIDE TEST | Aug 13, 1981 | Substantially Equivalent |
| K811375 | BI-RA SLIDE TEST | Jun 12, 1981 | Substantially Equivalent |
| K800605 | ANA LATEX SLIDE TEST | Apr 2, 1980 | Substantially Equivalent |
| K791609 | BE-SURE | Oct 2, 1979 | Substantially Equivalent |
| K791607 | BETA-CELL | Sep 24, 1979 | Substantially Equivalent |
| K790898 | PREG-TEX | Jul 30, 1979 | Substantially Equivalent |