FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIA OIA
K Number: K951010
·
Decision Oct 7, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
6
Review Days
215
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Basic Information
- Device Name
- CHLAMYDIA OIA
- K Number
- K951010
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biostar, Inc.
- Date Received
- March 6, 1995
- Decision Date
- October 7, 1995
- Product Code
- LJC
- 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | FDA class 1 | Microbiology |
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Other Clearances by Biostar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991829 | CDTOX A OIA | Nov 2, 1999 | Substantially Equivalent |
| K991828 | STREP B OIA | Aug 19, 1999 | Substantially Equivalent |
| K981651 | AB FLU OIA | Nov 25, 1998 | Substantially Equivalent |
| K962060 | STREP A OIA MAX | Jul 23, 1997 | Substantially Equivalent |
| K936112 | STREP B OIA | Jul 6, 1994 | Substantially Equivalent |