FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROPAPER EIKEN 8
K Number: K843532
·
Decision Dec 12, 1984
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
34
Review Days
96
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UROPAPER EIKEN 8
- K Number
- K843532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Syn-Kit, Inc.
- Date Received
- September 7, 1984
- Decision Date
- December 12, 1984
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHE), ordered by most recent decision date.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
FDA 510(k)
FDA Class 2
·Hematology
InSure ONE
FDA 510(k)
FDA Class 2
·Hematology
hema-screen SPECIFIC Gold
FDA 510(k)
FDA Class 2
·Hematology
Wondfo One Step Fecal Occult Blood (FOB) Test
FDA 510(k)
FDA Class 2
·Hematology
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
FDA 510(k)
FDA Class 2
·Hematology
OC-Light S FIT
FDA 510(k)
FDA Class 2
·Hematology
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 |