FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROUND 1
K Number: K873086
·
Decision Aug 24, 1987
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
13
Review Days
18
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Basic Information
- Device Name
- ROUND 1
- K Number
- K873086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bioclinical Systems, Inc.
- Date Received
- August 6, 1987
- Decision Date
- August 24, 1987
- 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 Bioclinical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Jun 30, 1995 | Substantially Equivalent |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS | Apr 4, 1995 | Substantially Equivalent |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Feb 9, 1994 | Substantially Equivalent |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Feb 3, 1994 | Substantially Equivalent |
| K860334 | VISI-CHECK HLH TEST MONOCLONAL | Apr 21, 1986 | Substantially Equivalent |
| K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL | Apr 21, 1986 | Substantially Equivalent |
| K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL | Apr 11, 1986 | Substantially Equivalent |
| K854059 | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO | Jan 13, 1986 | Substantially Equivalent |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | Jan 7, 1986 | Substantially Equivalent |
| K850257 | BCS GLUCOSE COLORIMETRIC TEST | Mar 5, 1985 | Substantially Equivalent |