FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIPLE SUGAR IRON
K Number: K842850
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
7
Review Days
28
Basic Information
- Device Name
- TRIPLE SUGAR IRON
- K Number
- K842850
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- ANAROBE SYSTEMS
- Date Received
- July 20, 1984
- Decision Date
- August 17, 1984
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by ANAROBE SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K842854 | MUELLER HINTON BROTH | Aug 17, 1984 | Substantially Equivalent |
| K842851 | ORNITHINE INDOLE MOTILITY | Aug 7, 1984 | Substantially Equivalent |
| K842853 | LYSINE IRON AGAR | Aug 3, 1984 | Substantially Equivalent |
| K842852 | BRAIN HEART INFUSION BROTH | Aug 3, 1984 | Substantially Equivalent |
| K842849 | TRYPTICASE SOY BROTH | Aug 3, 1984 | Substantially Equivalent |
| K842855 | CHRISTENSEN'S UREA AGAR | Aug 3, 1984 | Substantially Equivalent |