FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTIS COLUMBIA SHEEP BLOOD AGAR
K Number: K860409
·
Decision Feb 24, 1986
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
208
Applicant Total
98
Review Days
21
Basic Information
- Device Name
- BIOTIS COLUMBIA SHEEP BLOOD AGAR
- K Number
- K860409
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- OTISVILLE BIOTECH, INC.
- Date Received
- February 3, 1986
- Decision Date
- February 24, 1986
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSG), ordered by most recent decision date.
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007
FDA 510(k)
FDA Class 1
·Microbiology
COOKED MEAT MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
TRYPTOSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
TRYPTONE
FDA 510(k)
FDA Class 1
·Microbiology
HEART INFUSION AGAR
FDA 510(k)
FDA Class 1
·Microbiology
CASEIN PEPTONE, LOW VITAMIN
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by OTISVILLE BIOTECH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | Jul 3, 1986 | Substantially Equivalent |
| K862389 | BIOTIS ACETAMIDE AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE | Jul 3, 1986 | Substantially Equivalent |
| K862400 | BIOTIS KV LAKED BLOOD AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862391 | BIOTIS DESOXYCHOLATE AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | Jul 3, 1986 | Substantially Equivalent |
| K862393 | BIOTIS LITMUS MILK | Jul 3, 1986 | Substantially Equivalent |
| K862388 | BIOTIS TCBS AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | Jul 3, 1986 | Substantially Equivalent |
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | Jul 3, 1986 | Substantially Equivalent |