FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K Number: K823850
·
Decision Mar 1, 1983
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
38
Review Days
70
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Basic Information
- Device Name
- BAC-T-SCREEN BACTERIURIA DETECTION DEV
- K Number
- K823850
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- December 21, 1982
- Decision Date
- March 1, 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 Marion Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 5, 1988 | Substantially Equivalent |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | May 27, 1988 | Substantially Equivalent |
| K874554 | ENVICLUSIVE (TM) | Mar 11, 1988 | Substantially Equivalent |
| K874551 | ENVINET(TM) | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874552 | ENVISAN PAD | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874553 | ENVISAN PASTE | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Apr 14, 1987 | Substantially Equivalent |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Sep 17, 1986 | Substantially Equivalent |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent |