FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIFFERENTIAL CULTURE MED. MANNITOL SALT
K Number: K841841
·
Decision May 25, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
14
Review Days
38
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Basic Information
- Device Name
- DIFFERENTIAL CULTURE MED. MANNITOL SALT
- K Number
- K841841
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Microline Scientific
- Date Received
- April 17, 1984
- Decision Date
- May 25, 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 |
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Other Clearances by Microline Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K841586 | CHOCOLATE AGAR | May 31, 1984 | Substantially Equivalent |
| K841843 | DIFFERENTIAL CULTURE MED. LEVINE EMB | May 31, 1984 | Substantially Equivalent |
| K841844 | DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR | May 31, 1984 | Substantially Equivalent |
| K841842 | DIFFERENTIAL CULTURE MED. MACCONKEY AGAR | May 31, 1984 | Substantially Equivalent |
| K841845 | SELECTIVE CULTURE MED. COLUMBIA CNA | May 31, 1984 | Substantially Equivalent |
| K841840 | SELECTIVE CULTURE MED. PHENYLETHYL ALCO | May 25, 1984 | Substantially Equivalent |
| K841839 | SELECTIVE CULTURE MED. SELECTIVE STREP | May 25, 1984 | Substantially Equivalent |
| K841837 | ENRICHED CULTURE MED. FLUID THIOGLYC0 | May 21, 1984 | Substantially Equivalent |
| K841838 | ENRICHED CULTURE MED. TRYPTIC SOY AGAR | May 21, 1984 | Substantially Equivalent |
| K841836 | SELECTIVE CULTURE MED. TRICHOMONAS | May 14, 1984 | Substantially Equivalent |