FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PYLORISCREEN
K Number: K925190
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
10
Review Days
160
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Basic Information
- Device Name
- PYLORISCREEN
- K Number
- K925190
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- New Horizons Diagnostics Co.
- Date Received
- October 14, 1992
- Decision Date
- March 23, 1993
- Product Code
- LYR
- 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 |
|---|---|---|---|
| LYR | Helicobacter Pylori | FDA class 1 | Microbiology |
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Other Clearances by New Horizons Diagnostics Co.
| K Number | Device Name | ||
|---|---|---|---|
| K932622 | CHOLERA SMART(TM) | Jun 27, 1995 | Substantially Equivalent |
| K922432 | CHOLERASCREEN | Dec 7, 1992 | Substantially Equivalent |
| K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST | Feb 19, 1988 | Substantially Equivalent |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | May 28, 1987 | Substantially Equivalent |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | May 13, 1987 | Substantially Equivalent |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | Jun 30, 1986 | Substantially Equivalent |
| K851132 | LATEX AGGLUTINATION TEST | Jul 5, 1985 | Substantially Equivalent |
| K821362 | IMPROVED GONO GEN | Aug 4, 1982 | Substantially Equivalent |
| K820007 | NEISSERIA GONORRHOEAE TEST | Jan 29, 1982 | Substantially Equivalent |