FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K Number: K896474
·
Decision Jan 25, 1990
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
17
Review Days
73
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Basic Information
- Device Name
- RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
- K Number
- K896474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Labsystems, Inc.
- Date Received
- November 13, 1989
- Decision Date
- January 25, 1990
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
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Other Clearances by Labsystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923365 | TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM | Mar 24, 1993 | Substantially Equivalent |
| K890154 | MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA | Feb 7, 1989 | Substantially Equivalent |
| K890091 | MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT | Feb 3, 1989 | Substantially Equivalent |
| K881243 | RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 | Apr 4, 1988 | Substantially Equivalent |
| K873780 | MODIFICATION RUBELLA IGM EIA TEST KIT | Oct 15, 1987 | Substantially Equivalent |
| K873583 | AUTO-EIA | Sep 22, 1987 | Substantially Equivalent |
| K872252 | MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT | Jul 1, 1987 | Substantially Equivalent |
| K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Oct 1, 1986 | Substantially Equivalent |
| K862431 | RUBELLA IGM EIA TEST KIT | Aug 8, 1986 | Substantially Equivalent |
| K862216 | TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) | Jun 30, 1986 | Substantially Equivalent |