FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIATROL AG
K Number: K972129
·
Decision Aug 12, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
2
Applicant Total
4
Review Days
67
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Basic Information
- Device Name
- CHLAMYDIATROL AG
- K Number
- K972129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blackhawk Biosystems, Inc.
- Date Received
- June 6, 1997
- Decision Date
- August 12, 1997
- Product Code
- MJZ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| MJZ | Kit, Direct Antigen, Positive Control | FDA class 1 | Clinical Chemistry |
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