FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIA (LGV-1)
K Number: K894625
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
14
Review Days
26
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Basic Information
- Device Name
- CHLAMYDIA (LGV-1)
- K Number
- K894625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bion Ent., Ltd.
- Date Received
- July 20, 1989
- Decision Date
- August 15, 1989
- Product Code
- LKI
- 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 |
|---|---|---|---|
| LKI | Antisera, Fluorescent, Chlamydia Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKI), ordered by most recent decision date.
IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
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BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
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MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
FDA 510(k)
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·Microbiology
CULUTURE SET CHLAMYDIA ISOLATION AND
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| 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 |