FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
K Number: K790375
·
Decision Mar 15, 1979
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
47
Review Days
20
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Basic Information
- Device Name
- TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
- K Number
- K790375
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granite Diagnostics, Inc.
- Date Received
- February 23, 1979
- Decision Date
- March 15, 1979
- Product Code
- JSG
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-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 |
| K832365 | TCBS AGAR | Sep 1, 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 |