New Horizons Diagnostics Co.
Mchenry, IL, US
New Horizons Diagnostics Co. appears in FDA device records in Mchenry, IL. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for New Horizons Diagnostics Co. between 1982 and 1995. The busiest year on record is 1982, with 2. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K932622 | CHOLERA SMART(TM) | GSQ | Substantially Equivalent | |
| K925190 | PYLORISCREEN | LYR | Substantially Equivalent | |
| K922432 | CHOLERASCREEN | GSQ | Substantially Equivalent | |
| K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST | GTZ | Substantially Equivalent | |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | GMQ | Substantially Equivalent | |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | LIC | Substantially Equivalent | |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | JXA | Substantially Equivalent | |
| K851132 | LATEX AGGLUTINATION TEST | GTZ | Substantially Equivalent | |
| K821362 | IMPROVED GONO GEN | LIC | Substantially Equivalent | |
| K820007 | NEISSERIA GONORRHOEAE TEST | LIC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain