FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTIS (TM) BCYE
K Number: K874177
·
Decision Dec 4, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
50
Applicant Total
8
Review Days
50
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Basic Information
- Device Name
- BIOTIS (TM) BCYE
- K Number
- K874177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Otisville Biopharm, Inc.
- Date Received
- October 15, 1987
- Decision Date
- December 4, 1987
- Product Code
- KZI
- 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 |
|---|---|---|---|
| KZI | Culture Media, Enriched | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZI), ordered by most recent decision date.
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
FDA 510(k)
FDA Class 1
·Microbiology
DIAMOND'S MEDIUM MODIFIED
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FDA Class 1
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LOWENSTEIN-JENSEN, GRUFT
FDA 510(k)
FDA Class 1
·Microbiology
MIDDLEBROOK 7H11 AGAR
FDA 510(k)
FDA Class 1
·Microbiology
MIDDLEBROOK 7H9 BROTH
FDA 510(k)
FDA Class 1
·Microbiology
WALLENSTEIN MEDIUM SLANT
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Otisville Biopharm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874176 | BIOTIS (TM) HAEMOPHILUS DUCREYI | Feb 5, 1988 | Substantially Equivalent |
| K874179 | BIOTIS (TM) SABHI (DOUBLE POUR) | Jan 28, 1988 | Substantially Equivalent |
| K874174 | BIOTIS (TM) STARCH HYDROLYSIS WITH BCP | Dec 4, 1987 | Substantially Equivalent |
| K874175 | BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC | Dec 4, 1987 | Substantially Equivalent |
| K874178 | BIOTIS (TM) BCYE SELECTIVE | Dec 4, 1987 | Substantially Equivalent |
| K874173 | BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI | Oct 28, 1987 | Substantially Equivalent |
| K874172 | BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) | Oct 28, 1987 | Substantially Equivalent |