FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K Number: K973707
·
Decision Aug 4, 1999
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
51
Review Days
674
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Basic Information
- Device Name
- ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K Number
- K973707
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Molecular Systems, Inc.
- Date Received
- September 29, 1997
- Decision Date
- August 4, 1999
- Product Code
- MKZ
- 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 |
|---|---|---|---|
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | FDA class 1 | Microbiology |
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