FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
K Number: K873670
·
Decision Jun 8, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
4
Review Days
271
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Basic Information
- Device Name
- SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
- K Number
- K873670
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Molecular Biosystems, Inc.
- Date Received
- September 11, 1987
- Decision Date
- June 8, 1988
- Product Code
- LQO
- 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 |
|---|---|---|---|
| LQO | Dna-Reagents, Campylobacter Spp. | FDA class 1 | Microbiology |
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