FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASO SLIDE EIKEN
K Number: K853276
·
Decision Aug 20, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
34
Review Days
15
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Basic Information
- Device Name
- ASO SLIDE EIKEN
- K Number
- K853276
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Syn-Kit, Inc.
- Date Received
- August 5, 1985
- Decision Date
- August 20, 1985
- 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
Other 510(k) clearances with the same product code (GTQ), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
FDA 510(k)
FDA Class 1
·Microbiology
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
FDA 510(k)
FDA Class 1
·Microbiology
TURBIQUANT ASL
FDA 510(k)
FDA Class 1
·Microbiology
BECKMAN ANTI-STREPTOLYSIN O KIT
FDA 510(k)
FDA Class 1
·Microbiology
ACCUTEX ASO LATEX TEST
FDA 510(k)
FDA Class 1
·Microbiology
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Syn-Kit, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861098 | SEROIDEN STREPTO KIT 'EIKEN' | Aug 12, 1986 | Substantially Equivalent |
| K861631 | SLIDE CULTURE U 'EIKEN' | Jun 10, 1986 | Substantially Equivalent |
| K854819 | CPR SLIDE EIKEN | Feb 26, 1986 | Substantially Equivalent |
| K854820 | RA 80 EIKEN | Jan 17, 1986 | Substantially Equivalent |
| K843758 | UROPAPER EIKEN GK | Dec 18, 1984 | Substantially Equivalent |
| K843753 | UROPAPER EIKEN GP | Dec 18, 1984 | Substantially Equivalent |
| K843754 | UROPAPER EIKEN 7 | Dec 18, 1984 | Substantially Equivalent |
| K843760 | UROPAPER EIKEN G | Dec 18, 1984 | Substantially Equivalent |
| K843756 | UROPAPER EIKEN 5 | Dec 18, 1984 | Substantially Equivalent |
| K843759 | UROPAPER EIKEN HAG | Dec 18, 1984 | Substantially Equivalent |