FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR
K Number: K844526
·
Decision Jan 7, 1985
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
251
Review Days
47
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Basic Information
- Device Name
- THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR
- K Number
- K844526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- bioMerieux, Inc.
- Date Received
- November 21, 1984
- Decision Date
- January 7, 1985
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | FDA class 1 | Microbiology |
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