FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIPCHEX DIP-SLIDE CULTURE SYS
K Number: K830252
·
Decision Mar 7, 1983
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
47
Review Days
41
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Basic Information
- Device Name
- DIPCHEX DIP-SLIDE CULTURE SYS
- K Number
- K830252
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Granite Diagnostics, Inc.
- Date Received
- January 25, 1983
- Decision Date
- March 7, 1983
- Product Code
- JXA
- 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 |
|---|---|---|---|
| JXA | Kit, Screening, Urine | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXA), ordered by most recent decision date.
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
FDA 510(k)
FDA Class 1
·Microbiology
URISCREEN
FDA 510(k)
FDA Class 1
·Microbiology
URINE SCREENING DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
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 |
| 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 |
| K822997 | STREP SELECTIVE AGAR | Nov 17, 1982 | Substantially Equivalent |