FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEROIDEN STREPTO KIT 'EIKEN'
K Number: K861098
·
Decision Aug 12, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
34
Review Days
141
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Basic Information
- Device Name
- SEROIDEN STREPTO KIT 'EIKEN'
- K Number
- K861098
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Syn-Kit, Inc.
- Date Received
- March 24, 1986
- Decision Date
- August 12, 1986
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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Other Clearances by Syn-Kit, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K853276 | ASO SLIDE EIKEN | Aug 20, 1985 | 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 |