FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETA-2 MICROGLOBULIN EIA
K Number: K901333
·
Decision Apr 2, 1990
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
52
Applicant Total
5
Review Days
13
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Basic Information
- Device Name
- BETA-2 MICROGLOBULIN EIA
- K Number
- K901333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5630
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Serex, Inc.
- Date Received
- March 20, 1990
- Decision Date
- April 2, 1990
- Product Code
- JZG
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZG), ordered by most recent decision date.
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Other Clearances by Serex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923314 | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | Aug 24, 1992 | Substantially Equivalent |
| K921834 | AUTOMATES COMA COCAINE METABOLITE ASSAY | Jun 15, 1992 | Substantially Equivalent |
| K895043 | COMA COCAINE METABOLITE ASSAY (EIA) | Nov 8, 1989 | Substantially Equivalent |
| K890694 | BETA-2 MICROGLOBULIN EIA | Mar 16, 1989 | Substantially Equivalent |