FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
K Number: K851249
·
Decision Apr 22, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
296
Review Days
26
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Basic Information
- Device Name
- SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
- K Number
- K851249
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- March 27, 1985
- Decision Date
- April 22, 1985
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
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