FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BION DIRECT IDENTIFICATION CONTROL SLIDE
K Number: K890616
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
26
Applicant Total
14
Review Days
10
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Basic Information
- Device Name
- BION DIRECT IDENTIFICATION CONTROL SLIDE
- K Number
- K890616
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bion Ent., Ltd.
- Date Received
- February 7, 1989
- Decision Date
- February 17, 1989
- Product Code
- LJG
- 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 |
|---|---|---|---|
| LJG | Quality Control Slides | FDA class 1 | 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 |
| K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | Apr 5, 1990 | 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 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Jun 7, 1988 | Substantially Equivalent |