FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
ANTI-GBM ANTIBODIES QUANTITATIVE KIT
K Number: K904181
·
Decision Sep 10, 1991
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
5
Review Days
364
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Basic Information
- Device Name
- ANTI-GBM ANTIBODIES QUANTITATIVE KIT
- K Number
- K904181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Biochemical Diagnostic, Inc.
- Date Received
- September 11, 1990
- Decision Date
- September 10, 1991
- Product Code
- DBL
- 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 |
|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Biochemical Diagnostic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Jul 3, 2012 | Substantially Equivalent |
| K050328 | PREGNANCY-SKREEN | Mar 29, 2005 | Substantially Equivalent |
| K925586 | DETECTABUSE(TM) | Dec 28, 1992 | Substantially Equivalent |
| K841831 | CANNU-SKREEN-PRELIMINARY | Jul 6, 1984 | Substantially Equivalent |