FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MACCONKEY AGAR
K Number: K841753
·
Decision Jun 7, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
11
Review Days
41
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
- MACCONKEY AGAR
- K Number
- K841753
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- The Montana Deaconess Medical Center
- Date Received
- April 27, 1984
- Decision Date
- June 7, 1984
- 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 The Montana Deaconess Medical Center
| K Number | Device Name | ||
|---|---|---|---|
| K841752 | XYLOSE-LYSINE DESOXYCHOLATE AGAR | Jun 7, 1984 | Substantially Equivalent |
| K841747 | MANNITOL SALT AGAR | Jun 7, 1984 | Substantially Equivalent |
| K841749 | CHOCOLATE AGAR | May 31, 1984 | Substantially Equivalent |
| K841748 | SHEEP BLOOD AGAR | May 31, 1984 | Substantially Equivalent |
| K841751 | LEVINE EOSIN METHYLENE BLUE AGAR | May 31, 1984 | Substantially Equivalent |
| K841746 | SALMONELLA-SHIGELLA AGAR | May 31, 1984 | Substantially Equivalent |
| K841750 | MARTIN-LEWIS AGAR | May 31, 1984 | Substantially Equivalent |
| K841755 | MUELLER-HINTON AGAR | May 14, 1984 | Substantially Equivalent |
| K841745 | HEKTOEN ENTERIC AGAR | May 11, 1984 | Substantially Equivalent |
| K841754 | COLUMBIA CNA AGAR | May 7, 1984 | Substantially Equivalent |