The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Hcg Pregnancy Urine Dipstick, Hcg Pregnancy Urine Cassette Test, And Hcg Combo Serum/urine Cassette Test.
| Device ID | K123844 |
| 510k Number | K123844 |
| Device Name: | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | CHEMTRON BIOTECH, INC. 9245 Brown Deer Rd San Diego, CA 92121 |
| Contact | Jane Zhang |
| Correspondent | Jane Zhang CHEMTRON BIOTECH, INC. 9245 Brown Deer Rd San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-13 |
| Decision Date | 2013-05-30 |
| Summary: | summary |