The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Cholera Smart(tm).
Device ID | K932622 |
510k Number | K932622 |
Device Name: | CHOLERA SMART(TM) |
Classification | Antiserum, Vibrio Cholerae, All Varieties |
Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
Contact | John Tartal |
Correspondent | John Tartal NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
Product Code | GSQ |
CFR Regulation Number | 866.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-01 |
Decision Date | 1995-06-27 |