FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBELLA IGM EIA TEST KIT
K Number: K862431
·
Decision Aug 8, 1986
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
17
Review Days
43
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Basic Information
- Device Name
- RUBELLA IGM EIA TEST KIT
- K Number
- K862431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Labsystems, Inc.
- Date Received
- June 26, 1986
- Decision Date
- August 8, 1986
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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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 |
| K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA | Jan 25, 1990 | 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 |
| K862216 | TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) | Jun 30, 1986 | Substantially Equivalent |