FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
K Number: K850720
·
Decision Mar 22, 1985
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
10
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
- K Number
- K850720
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Rapid City Regional Hospital, Inc.
- Date Received
- February 22, 1985
- Decision Date
- March 22, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSI), ordered by most recent decision date.
BBL CHROMAGAR 0157
FDA 510(k)
FDA Class 1
·Microbiology
DIPSTREAK
FDA 510(k)
FDA Class 1
·Microbiology
LISTERIA SELECTIVE ENRICHMENT MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
DENTOCULT SM-STRIP MUTANS
FDA 510(k)
FDA Class 1
·Microbiology
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
FDA 510(k)
FDA Class 1
·Microbiology
MODIFIED SELECTIVE STREPTOCOCCUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K850716 | SELENITE F BROTH | Mar 22, 1985 | Substantially Equivalent |
| K850718 | CORN MEAL AGAR | Mar 20, 1985 | Substantially Equivalent |