The following data is part of a premarket notification filed by Excel Scientific, Inc. with the FDA for Excel One Step Urine Hcg Pregnancy Dipstick Test.
Device ID | K970424 |
510k Number | K970424 |
Device Name: | EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. Yorba Linda, CA 92887 |
Contact | Min-lee Cheng |
Correspondent | Min-lee Cheng EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. Yorba Linda, CA 92887 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-04 |
Decision Date | 1997-03-06 |
Summary: | summary |