FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAC-T-SCREEN
K Number: K833917
·
Decision Jan 13, 1984
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
10
Applicant Total
38
Review Days
60
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
- BAC-T-SCREEN
- K Number
- K833917
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- November 14, 1983
- Decision Date
- January 13, 1984
- Product Code
- JTA
- Advisory Committee
- Microbiology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JTA | Monitor, Microbial Growth | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTA), ordered by most recent decision date.
BACTEC FUNGAL MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
BACTEC NR-860
FDA 510(k)
FDA Class 1
·Microbiology
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
BACTEC NR-730 BACTERIAL DETECTION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
FDA 510(k)
FDA Class 1
·Microbiology
BECTEC NR-660 BACTERIAL DETECT SYS
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 |