FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MANNITOL SALT AGAR
K Number: K851585
·
Decision Apr 30, 1985
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
28
Review Days
14
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
- MANNITOL SALT AGAR
- K Number
- K851585
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Preferred Micro-Media
- Date Received
- April 16, 1985
- Decision Date
- April 30, 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 Preferred Micro-Media
| K Number | Device Name | ||
|---|---|---|---|
| K851594 | SF BROTH | May 14, 1985 | Substantially Equivalent |
| K851597 | TRIPLE SUGAR IRON AGAR | May 13, 1985 | Substantially Equivalent |
| K851591 | PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD | May 13, 1985 | Substantially Equivalent |
| K851592 | SABOURAUD DEXTROSE AGAR | May 13, 1985 | Substantially Equivalent |
| K851593 | SELECTIVE STREPTOCOCCUS AGAR | May 13, 1985 | Substantially Equivalent |
| K851595 | SIMMONS CITRATE AGAR | May 13, 1985 | Substantially Equivalent |
| K851596 | SIM MEDIUM | May 13, 1985 | Substantially Equivalent |
| K851598 | THIOGLYCOLLATE WITHOUT INDICATOR | May 10, 1985 | Substantially Equivalent |
| K851576 | BIGGY AGAR NICKERSONS MEDIUM | May 9, 1985 | Substantially Equivalent |
| K851599 | TRICHOMONAS BROTH (KUPFORBERG | May 8, 1985 | Substantially Equivalent |