FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLUMBIA AGAR WITH 5% RABBIT BLOOD
K Number: K780704
·
Decision May 12, 1978
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
284
Applicant Total
47
Review Days
17
Basic Information
- Device Name
- COLUMBIA AGAR WITH 5% RABBIT BLOOD
- K Number
- K780704
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- GRANITE DIAGNOSTICS, INC.
- Date Received
- April 25, 1978
- Decision Date
- May 12, 1978
- 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 | ||
|---|---|---|---|
| K850969 | INHIBITORY MOLD AGAR PLATE | Mar 29, 1985 | Substantially Equivalent |
| K850970 | BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA | 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 |
| K823122 | LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM | Dec 3, 1982 | Substantially Equivalent |
| K823139 | SMITH'S MEDIUM | Dec 3, 1982 | Substantially Equivalent |
| K823248 | SCHAEDLER AGARS | Dec 3, 1982 | Substantially Equivalent |