The following data is part of a premarket notification filed by Assure Tech. Co., Ltd. with the FDA for Assure Tech Hcg Pregnancy Serum/urine Combo Test Cassette, Assure Tech Hcg Pregnancy Serum/urine Combo Test Strip.
Device ID | K152768 |
510k Number | K152768 |
Device Name: | Assure Tech HCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech HCG Pregnancy Serum/Urine Combo Test Strip |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | ASSURE TECH. CO., LTD. 2ND. FLOOR, BUILDING 1, NO. 10, XIYUANSAN ROAD, Hangzhou, CN 310030 |
Contact | Eric Lin |
Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-24 |
Decision Date | 2016-02-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06952804801830 | K152768 | 000 |
06952804801212 | K152768 | 000 |
06952804801205 | K152768 | 000 |
06952804801090 | K152768 | 000 |