FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#2005 SABOURAUD DEXTROSE AGAR/#4002 SLA
K Number: K820805
·
Decision Apr 8, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
19
Review Days
16
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Basic Information
- Device Name
- #2005 SABOURAUD DEXTROSE AGAR/#4002 SLA
- K Number
- K820805
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biomedica, Inc.
- Date Received
- March 23, 1982
- Decision Date
- April 8, 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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| K Number | Device Name | ||
|---|---|---|---|
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| K820806 | #2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL | Apr 8, 1982 | Substantially Equivalent |
| K820795 | #4006 TSB-TUBED MEDIA | Apr 8, 1982 | Substantially Equivalent |
| K820807 | #2011 STREP SELECTIVE AGAR | Apr 8, 1982 | Substantially Equivalent |
| K820804 | #2013 CNA 5% SHEEP BLOOD | Apr 8, 1982 | Substantially Equivalent |
| K820800 | #2006 SALMONELLA SHIGELLA AGAR | Apr 8, 1982 | Substantially Equivalent |
| K820802 | #2009 BIGGY AGAR | Apr 8, 1982 | Substantially Equivalent |
| K820801 | #2007 XLD | Apr 8, 1982 | Substantially Equivalent |