FDA 510(k)
FDA class 1
Substantially Equivalent
🇪🇸 Spain
REUMAGEN ASL
K Number: K854991
·
Decision Apr 18, 1986
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
36
Applicant Total
16
Review Days
127
Basic Information
- Device Name
- REUMAGEN ASL
- K Number
- K854991
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- BIOKIT USA, INC.
- Date Received
- December 12, 1985
- Decision Date
- April 18, 1986
- 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 |
Similar 510(k) Clearances
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VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
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Other Clearances by BIOKIT USA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K913467 | TOXOGEN | Jan 11, 1993 | Substantially Equivalent |
| K910541 | BIOKIT RPR | Oct 18, 1991 | 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 |
| K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL | Nov 8, 1989 | Substantially Equivalent |
| K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) | Nov 8, 1989 | Substantially Equivalent |