FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOSEL AGAR W/CHLORAMPHENICOL &
K Number: K841135
·
Decision Mar 26, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
52
Review Days
10
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Basic Information
- Device Name
- MYCOSEL AGAR W/CHLORAMPHENICOL &
- K Number
- K841135
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Anaerobe Systems
- Date Received
- March 16, 1984
- Decision Date
- March 26, 1984
- 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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Other Clearances by Anaerobe Systems
| K Number | Device Name | ||
|---|---|---|---|
| K844381 | COLISTIN 10 MCG. DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K844382 | VANCOMYCIN 5MCG DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K844383 | KANAMYCIN 1000 MCG DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K844380 | BILE DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K841303 | CAMPYLOBACTER THIOGLYCOLLATE MED | Apr 17, 1984 | Substantially Equivalent |
| K841218 | CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR | Apr 5, 1984 | Substantially Equivalent |
| K841142 | LEVINE EOSIN METHYLENE BLUE AGAR | Apr 5, 1984 | Substantially Equivalent |
| K841221 | BRAIN HEART INFUSION BROTH | Apr 4, 1984 | Substantially Equivalent |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Apr 4, 1984 | Substantially Equivalent |
| K841222 | BACTEROIDES BILE ESCULIN GAR | Apr 4, 1984 | Substantially Equivalent |