FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELENITE BROTH
K Number: K832614
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
11
Review Days
66
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Basic Information
- Device Name
- SELENITE BROTH
- K Number
- K832614
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Carroll Biological Corp.
- Date Received
- July 8, 1983
- Decision Date
- September 12, 1983
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSJ), ordered by most recent decision date.
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YM BROTH
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MITIS SALIVARIUS AGAR
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W-L DIFFERENTIAL MEDIUM
FDA 510(k)
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·Microbiology
LITTMAN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Carroll Biological Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832243 | CULTURE MEDIUM FOR ANTIMICROBIAL SUS | Sep 29, 1983 | Substantially Equivalent |
| K832617 | XYLOSE LYSINE DEOXYCHOLATE | Sep 12, 1983 | Substantially Equivalent |
| K832615 | SF BROTH | Sep 12, 1983 | Substantially Equivalent |
| K832612 | CHOCOLATE AGAR & THAYER MARTIN AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832619 | THIOGLYCOLLATE MEDIUM | Sep 12, 1983 | Substantially Equivalent |
| K832620 | TRYPTIC SOY BROTH MEDIA | Sep 12, 1983 | Substantially Equivalent |
| K832611 | TRYPTIC SOY AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832613 | MANNITOL SALT AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832618 | BLUE AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832616 | MACCONKEY AGAR MEDIA | Sep 12, 1983 | Substantially Equivalent |