FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
K Number: K901054
·
Decision Apr 5, 1990
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
14
Review Days
30
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Basic Information
- Device Name
- BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
- K Number
- K901054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bion Ent., Ltd.
- Date Received
- March 6, 1990
- Decision Date
- April 5, 1990
- Product Code
- LSR
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
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Other Clearances by Bion Ent., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | Jun 15, 1993 | Substantially Equivalent |
| K894622 | VARICELLA ZOSTER VIRUS | Oct 24, 1989 | Substantially Equivalent |
| K894624 | MUMPS VIRUS | Oct 16, 1989 | Substantially Equivalent |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | Oct 16, 1989 | Substantially Equivalent |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Oct 16, 1989 | Substantially Equivalent |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Aug 31, 1989 | Substantially Equivalent |
| K894625 | CHLAMYDIA (LGV-1) | Aug 15, 1989 | Substantially Equivalent |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | Jul 14, 1989 | Substantially Equivalent |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | Feb 17, 1989 | Substantially Equivalent |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Jun 7, 1988 | Substantially Equivalent |