FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENRICHED CULTURE MED. TRYPTIC SOY AGAR
K Number: K841838
·
Decision May 21, 1984
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
50
Applicant Total
14
Review Days
34
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Basic Information
- Device Name
- ENRICHED CULTURE MED. TRYPTIC SOY AGAR
- K Number
- K841838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Microline Scientific
- Date Received
- April 17, 1984
- Decision Date
- May 21, 1984
- Product Code
- KZI
- 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 |
|---|---|---|---|
| KZI | Culture Media, Enriched | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZI), ordered by most recent decision date.
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
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DIAMOND'S MEDIUM MODIFIED
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LOWENSTEIN-JENSEN, GRUFT
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MIDDLEBROOK 7H11 AGAR
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FDA Class 1
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MIDDLEBROOK 7H9 BROTH
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FDA Class 1
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WALLENSTEIN MEDIUM SLANT
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K841841 | DIFFERENTIAL CULTURE MED. MANNITOL SALT | May 25, 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 |
| K841836 | SELECTIVE CULTURE MED. TRICHOMONAS | May 14, 1984 | Substantially Equivalent |