FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XYLOSE LYSINE DEOXYCHOLATE
K Number: K832617
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
11
Review Days
66
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Basic Information
- Device Name
- XYLOSE LYSINE DEOXYCHOLATE
- K Number
- K832617
- 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
- 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 Carroll Biological Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832243 | CULTURE MEDIUM FOR ANTIMICROBIAL SUS | Sep 29, 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 |
| K832614 | SELENITE BROTH | 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 |