FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DULTURE MEDIA, SELECTIVE & NON-DIFFER
K Number: K820845
·
Decision Apr 16, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
11
Review Days
21
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Basic Information
- Device Name
- DULTURE MEDIA, SELECTIVE & NON-DIFFER
- K Number
- K820845
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Blue Ridge Media Co.
- Date Received
- March 26, 1982
- Decision Date
- April 16, 1982
- 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 Blue Ridge Media Co.
| K Number | Device Name | ||
|---|---|---|---|
| K820843 | CULTURE MEDIA SELECTIVE BROTH | Apr 16, 1982 | Substantially Equivalent |
| K820839 | CULTURE MEDIA, SINGLE BIOCHEM. TEST | Apr 16, 1982 | Substantially Equivalent |
| K820848 | BLUE RIDGE SHEEP BLOOD | Apr 16, 1982 | Substantially Equivalent |
| K820841 | CULTURE MEDIA, MULTIPLE BIOCHEMICAL | Apr 16, 1982 | Substantially Equivalent |
| K820844 | CULTURE MEDIA, SELECTIVE & DIFFERENTIAL | Apr 16, 1982 | Substantially Equivalent |
| K820846 | ANTIMICROBIAL SUSCEP. TEST, MUELLER | Apr 16, 1982 | Substantially Equivalent |
| K820842 | CULTURE MEDIA, NON-SELECTIVE/DIFFER | Apr 16, 1982 | Substantially Equivalent |
| K820840 | CULTURE MEDIA, GENERAL NUTRIENT BROTH | Apr 16, 1982 | Substantially Equivalent |
| K820847 | ISOLATION OF PATHOGENIC NEISSERIA | Apr 16, 1982 | Substantially Equivalent |
| K820849 | BLUE RIDGE RABBIT BLOOD | Apr 16, 1982 | Substantially Equivalent |