510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112449Substantially Equivalent

Quikresponse One Step Midstream Early Pregrancy Test

Tianjin New Bay Bioresearch Co., Ltd., Yorba Linda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112449 is the FDA 510(k) clearance record for QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST, a class II device, cleared for Tianjin New Bay Bioresearch Co., Ltd. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 11 510(k) clearances for Tianjin New Bay Bioresearch Co., Ltd., from to . As of , FDA records show no recalls naming K112449.

Clearance record

Decision date
Received
(396 days to decision)
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tianjin New Bay Bioresearch Co., Ltd. 5230 Via Primaria, Yorba Linda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCX

Trailing 12 months

FDA records hold no clearances under product code LCX in the trailing twelve months.

FDA records show no clearances under product code LCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260