FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TCBS AGAR
K Number: K832365
·
Decision Sep 1, 1983
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
47
Review Days
45
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Basic Information
- Device Name
- TCBS AGAR
- K Number
- K832365
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granite Diagnostics, Inc.
- Date Received
- July 18, 1983
- Decision Date
- September 1, 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 Granite Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850970 | BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA | Mar 29, 1985 | Substantially Equivalent |
| K850969 | INHIBITORY MOLD AGAR PLATE | Mar 29, 1985 | Substantially Equivalent |
| K833254 | STREPTOCOCCUS ID TRIPLATE SYSTEM | Oct 28, 1983 | Substantially Equivalent |
| K831349 | STREPTOCOCUS ID PLATE | May 16, 1983 | Substantially Equivalent |
| K830252 | DIPCHEX DIP-SLIDE CULTURE SYS | Mar 7, 1983 | Substantially Equivalent |
| K830251 | CAMPY BLOOD AGAR PLATE | Feb 28, 1983 | Substantially Equivalent |
| K823139 | SMITH'S MEDIUM | Dec 3, 1982 | Substantially Equivalent |
| K823122 | LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM | Dec 3, 1982 | Substantially Equivalent |
| K823248 | SCHAEDLER AGARS | Dec 3, 1982 | Substantially Equivalent |
| K822997 | STREP SELECTIVE AGAR | Nov 17, 1982 | Substantially Equivalent |