FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
BIOKIT RPR
K Number: K910541
·
Decision Oct 18, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
16
Review Days
256
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Basic Information
- Device Name
- BIOKIT RPR
- K Number
- K910541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biokit USA, Inc.
- Date Received
- February 4, 1991
- Decision Date
- October 18, 1991
- Product Code
- GMQ
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
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Other Clearances by Biokit USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913467 | TOXOGEN | Jan 11, 1993 | Substantially Equivalent |
| K904310 | RHEUMAGEN RF T-CONTROL | May 31, 1991 | Substantially Equivalent |
| K910539 | RHEUMAJET RF | Apr 5, 1991 | Substantially Equivalent |
| K910686 | RHEUMAJET CRP | Mar 19, 1991 | Substantially Equivalent |
| K904311 | RHEUMAGEN ASO T-CONTROL | Jan 25, 1991 | Substantially Equivalent |
| K904312 | RHEUMAGEN CRP T-CONTROL | Oct 1, 1990 | Substantially Equivalent |
| K896433 | MODIFIED RUBAGEN | Nov 29, 1989 | Substantially Equivalent |
| K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) | Nov 8, 1989 | Substantially Equivalent |
| K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL | Nov 8, 1989 | Substantially Equivalent |
| K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) | Oct 24, 1989 | Substantially Equivalent |