FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORN MEAL AGAR
K Number: K850718
·
Decision Mar 20, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
10
Review Days
26
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Basic Information
- Device Name
- CORN MEAL AGAR
- K Number
- K850718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Rapid City Regional Hospital, Inc.
- Date Received
- February 22, 1985
- Decision Date
- March 20, 1985
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Rapid City Regional Hospital, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850724 | CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL | Mar 25, 1985 | Substantially Equivalent |
| K850719 | DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR | Mar 22, 1985 | Substantially Equivalent |
| K850717 | AMIES TRANSPORT MEDIA | Mar 22, 1985 | Substantially Equivalent |
| K850722 | MARTIN LEWIS AGAR | Mar 22, 1985 | Substantially Equivalent |
| K850721 | KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E | Mar 22, 1985 | Substantially Equivalent |
| K850723 | SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC | Mar 22, 1985 | Substantially Equivalent |
| K850715 | MUELLER HINTON AGAR | Mar 22, 1985 | Substantially Equivalent |
| K850720 | EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5% | Mar 22, 1985 | Substantially Equivalent |
| K850716 | SELENITE F BROTH | Mar 22, 1985 | Substantially Equivalent |