FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MACCONKEY AGAR
K Number: K811611
·
Decision Jun 25, 1981
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
52
Review Days
17
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Basic Information
- Device Name
- MACCONKEY AGAR
- K Number
- K811611
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Micro Media Laboratories
- Date Received
- June 8, 1981
- Decision Date
- June 25, 1981
- 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 Micro Media Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K853691 | TERGITOL 7 AGAR | Sep 17, 1985 | Substantially Equivalent |
| K853690 | COLUMBIZ BLOOD AGAR | Sep 17, 1985 | Substantially Equivalent |
| K851344 | OXIDATIVE FORMENTIVE MEDIUM | Apr 22, 1985 | Substantially Equivalent |
| K851343 | BROM CRESOL PURPLE STARCH | Apr 19, 1985 | Substantially Equivalent |
| K851348 | COBA AGAR | Apr 19, 1985 | Substantially Equivalent |
| K851347 | KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR | Apr 19, 1985 | Substantially Equivalent |
| K851345 | PURPLE BROTH | Apr 19, 1985 | Substantially Equivalent |
| K851346 | PHENYLALANINE AGAR | Apr 19, 1985 | Substantially Equivalent |
| K850848 | BRAIN HEART INFUSION AGAR | Mar 20, 1985 | Substantially Equivalent |
| K850846 | SALT BROTH | Mar 20, 1985 | Substantially Equivalent |