The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for One-step Urine/serum Comno Pregnancy Dipstick Test.
Device ID | K964462 |
510k Number | K964462 |
Device Name: | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
Contact | Andrew Reams |
Correspondent | Andrew Reams TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-07 |
Decision Date | 1997-02-11 |