FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYFO-KWIK OMI KIT
K Number: K851978
·
Decision Jun 4, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
48
Applicant Total
9
Review Days
28
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
- LYFO-KWIK OMI KIT
- K Number
- K851978
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Micro-Bio-Logics
- Date Received
- May 7, 1985
- Decision Date
- June 4, 1985
- Product Code
- JSS
- 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 |
|---|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSS), ordered by most recent decision date.
hemoFISH Masterpanel
FDA 510(k)
FDA Class 1
·Microbiology
GRAM-NEGATIVE QUICKFISH BC
FDA 510(k)
FDA Class 1
·Microbiology
GNR TRAFFIC LIGHT PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
E.COLI/P. AERUGINOSA PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
EK/P. AERUGINOSA PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
E. COLI PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Micro-Bio-Logics
| K Number | Device Name | ||
|---|---|---|---|
| K870731 | LYFO KWIK(TM) RUS KIT | Jun 17, 1987 | Substantially Equivalent |
| K861312 | LYFO-KWIK (TM) COAGULASE PLASMA | Apr 18, 1986 | Substantially Equivalent |
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS | Apr 4, 1986 | Substantially Equivalent |
| K855172 | KWI (TM) G-CO/TWO | Feb 20, 1986 | Substantially Equivalent |
| K855198 | INDI KWIK (TM) CO/TWO KIT | Jan 14, 1986 | Substantially Equivalent |
| K852998 | NEISSERIA - KWIK PLUS | Jul 23, 1985 | Substantially Equivalent |
| K844014 | ONO/CO-TWO (TM) SYSTEMS | Oct 31, 1984 | Substantially Equivalent |
| K842129 | LYFO-DISK MICROORGANISMS | Jul 3, 1984 | Substantially Equivalent |