FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTIS (TM) HAEMOPHILUS DUCREYI
K Number: K874176
·
Decision Feb 5, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
8
Review Days
115
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIOTIS (TM) HAEMOPHILUS DUCREYI
- K Number
- K874176
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Otisville Biopharm, Inc.
- Date Received
- October 13, 1987
- Decision Date
- February 5, 1988
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSJ), ordered by most recent decision date.
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421
FDA 510(k)
FDA Class 1
·Microbiology
INHIBITORY MOLD AGAR
FDA 510(k)
FDA Class 1
·Microbiology
YM BROTH
FDA 510(k)
FDA Class 1
·Microbiology
MITIS SALIVARIUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
W-L DIFFERENTIAL MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
LITTMAN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Otisville Biopharm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874179 | BIOTIS (TM) SABHI (DOUBLE POUR) | Jan 28, 1988 | Substantially Equivalent |
| K874174 | BIOTIS (TM) STARCH HYDROLYSIS WITH BCP | Dec 4, 1987 | Substantially Equivalent |
| K874177 | BIOTIS (TM) BCYE | 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 |