FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECIALTY MEDIA
K Number: K873259
·
Decision Nov 6, 1987
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
14
Review Days
87
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Basic Information
- Device Name
- SPECIALTY MEDIA
- K Number
- K873259
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Central Media
- Date Received
- August 11, 1987
- Decision Date
- November 6, 1987
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Central Media
| K Number | Device Name | ||
|---|---|---|---|
| K873257 | GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. | Nov 6, 1987 | Substantially Equivalent |
| K873258 | STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA | Nov 6, 1987 | Substantially Equivalent |
| K873260 | CORYNEBACTERIA ISOLATION MEDIA | Nov 6, 1987 | Substantially Equivalent |
| K873267 | ECG BASED MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873270 | ACTINOMYCETE DIFFERENTIAL MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873268 | MUELLER HINTON MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873269 | MYCOLOGICAL MEDIA | Nov 4, 1987 | Substantially Equivalent |
| K873262 | DIFFERENTIAL MEDIA | Oct 28, 1987 | Substantially Equivalent |
| K873266 | MIDDLEBROOK BASED MEDIA | Oct 28, 1987 | Substantially Equivalent |
| K873265 | MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION | Oct 28, 1987 | Substantially Equivalent |