FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TREP CARD EIKEN
K Number: K820567
·
Decision Apr 14, 1982
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
34
Review Days
43
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Basic Information
- Device Name
- TREP CARD EIKEN
- K Number
- K820567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Syn-Kit, Inc.
- Date Received
- March 2, 1982
- Decision Date
- April 14, 1982
- 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 |
Similar 510(k) Clearances
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THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
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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 |
| 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 |