FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RICE EXTRACT AGAR
K Number: K823071
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
47
Review Days
17
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
- RICE EXTRACT AGAR
- K Number
- K823071
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granite Diagnostics, Inc.
- Date Received
- October 19, 1982
- Decision Date
- November 5, 1982
- Product Code
- JSH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- PA
- 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 Granite Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850970 | BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA | Mar 29, 1985 | Substantially Equivalent |
| K850969 | INHIBITORY MOLD AGAR PLATE | Mar 29, 1985 | Substantially Equivalent |
| K833254 | STREPTOCOCCUS ID TRIPLATE SYSTEM | Oct 28, 1983 | Substantially Equivalent |
| K832365 | TCBS AGAR | Sep 1, 1983 | Substantially Equivalent |
| K831349 | STREPTOCOCUS ID PLATE | May 16, 1983 | Substantially Equivalent |
| K830252 | DIPCHEX DIP-SLIDE CULTURE SYS | Mar 7, 1983 | Substantially Equivalent |
| K830251 | CAMPY BLOOD AGAR PLATE | Feb 28, 1983 | Substantially Equivalent |
| K823139 | SMITH'S MEDIUM | Dec 3, 1982 | Substantially Equivalent |
| K823122 | LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM | Dec 3, 1982 | Substantially Equivalent |
| K823248 | SCHAEDLER AGARS | Dec 3, 1982 | Substantially Equivalent |