FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BRAIN HEART INFUSION AGAR
K Number: K850848
·
Decision Mar 20, 1985
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
52
Review Days
19
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Basic Information
- Device Name
- BRAIN HEART INFUSION AGAR
- K Number
- K850848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Micro Media Laboratories
- Date Received
- March 1, 1985
- Decision Date
- March 20, 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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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 |
| K850846 | SALT BROTH | Mar 20, 1985 | Substantially Equivalent |
| K850844 | V AGAR | Mar 20, 1985 | Substantially Equivalent |