FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTIS LOWENSTEIN-JENSEN MEDIA
K Number: K843769
·
Decision Oct 10, 1984
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
98
Review Days
15
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 LOWENSTEIN-JENSEN MEDIA
- K Number
- K843769
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Otisville Biotech, Inc.
- Date Received
- September 25, 1984
- Decision Date
- October 10, 1984
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSH), ordered by most recent decision date.
FLO AGAR
FDA 510(k)
FDA Class 1
·Microbiology
UREA AGAR BASE
FDA 510(k)
FDA Class 1
·Microbiology
UREA BROTH
FDA 510(k)
FDA Class 1
·Microbiology
DNASE TEST AGAR
FDA 510(k)
FDA Class 1
·Microbiology
RUSSELL DOUBLE SUGAR AGAR
FDA 510(k)
FDA Class 1
·Microbiology
PHENOL RED BROTH BASE
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Otisville Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | Jul 3, 1986 | Substantially Equivalent |
| K862389 | BIOTIS ACETAMIDE AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862393 | BIOTIS LITMUS MILK | Jul 3, 1986 | Substantially Equivalent |
| K862392 | BIOTIS MOTILITY TEST MEDIUM | Jul 3, 1986 | Substantially Equivalent |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | Jul 3, 1986 | Substantially Equivalent |
| K862388 | BIOTIS TCBS AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862399 | BIOTIS SXT AGAR | Jul 3, 1986 | Substantially Equivalent |
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | Jul 3, 1986 | Substantially Equivalent |
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | Jul 3, 1986 | Substantially Equivalent |
| K862394 | BIOTIS MITIS SALIVARIUS | Jul 3, 1986 | Substantially Equivalent |