FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTIS TCBS AGAR
K Number: K862388
·
Decision Jul 3, 1986
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
98
Review Days
9
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 TCBS AGAR
- K Number
- K862388
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Otisville Biotech, Inc.
- Date Received
- June 24, 1986
- Decision Date
- July 3, 1986
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSI), ordered by most recent decision date.
BBL CHROMAGAR 0157
FDA 510(k)
FDA Class 1
·Microbiology
DIPSTREAK
FDA 510(k)
FDA Class 1
·Microbiology
LISTERIA SELECTIVE ENRICHMENT MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
DENTOCULT SM-STRIP MUTANS
FDA 510(k)
FDA Class 1
·Microbiology
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
FDA 510(k)
FDA Class 1
·Microbiology
MODIFIED SELECTIVE STREPTOCOCCUS AGAR
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 |
| 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 |
| K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE | Jul 3, 1986 | Substantially Equivalent |