ClearanceBrief
Panels › Clinical Chemistry › Product code LCX · Class 2

Kit, Test, Pregnancy, Hcg, Over The Counter

Regulation 862.1155

0510(k)s in 12 months (226 all time)
2recalls in 12 months (25 all time)
16recalls that name a 510(k)
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Top companies in LCX

DateFirm and productCodeLinked 510(k)
Jan 27, 2026GOLD STAR DISTRIBUTION INC
PREGNANCY TEST 24CT
Open, Classified
LCXNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Pregnancy Test
Open, Classified
LCXNone listed
Nov 7, 2023Family Dollar Stores, Llc.
FIRST RESPONSE 2 CT, SKU 902343
Open, Classified
LCXK123436
Nov 7, 2023Family Dollar Stores, Llc.
VERIQUICK PREGNANCY TEST 1CT, SKU 901260
Open, Classified
LCXK123703
Nov 7, 2023Family Dollar Stores, Llc.
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Open, Classified
LCXK200913
Oct 23, 2023Universal Meditech Inc.
DiagnosUS Pregnancy Test Midstream REF 100-17
Open, Classified
LCXK974059
Oct 23, 2023Universal Meditech Inc.
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Open, Classified
LCXK974059
Oct 23, 2023Universal Meditech Inc.
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
Open, Classified
LCXK110889
Oct 23, 2023Universal Meditech Inc.
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
Open, Classified
LCXK974059
Oct 23, 2023Universal Meditech Inc.
One Step Pregnancy Test REF 100-01
Open, Classified
LCXK110889
Apr 7, 2023Church & Dwight Inc
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e
Open, Classified
LCXK083716
Aug 17, 2022Family Dollar Stores, Llc.
FIRST RESPONSE 2 CT, SKU 902343
Open, Classified
LCXK123436
Aug 17, 2022Family Dollar Stores, Llc.
Veriquick Pregnancy Test 2CT, SKU 903756
Open, Classified
LCXK123703
Aug 17, 2022Family Dollar Stores, Llc.
VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
Open, Classified
LCXK123703
Aug 17, 2022Family Dollar Stores, Llc.
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Open, Classified
LCXK200913
Sep 25, 2010Inverness Medical Professional Diagnostics
UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.
Terminated
LCXNone listed
Sep 25, 2010Inverness Medical Professional Diagnostics
UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy.
Terminated
LCXNone listed
Mar 8, 2010Mainline Technology, Inc.
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
Terminated
LCXNone listed
Jan 5, 2007Mizuho USA, Inc.
Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) Note: (1) Confirm Clearly Starter Kits: When sold in the U
Terminated
LCXK060825
Jul 22, 2005Core Brands
Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico
Terminated
LCXNone listed
Jun 21, 2005Harmony Brands Llc
B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
Terminated
LCXNone listed
Jan 28, 2005International Chemical Inc.
OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99
Terminated
LCXNone listed
Jan 28, 2005International Chemical Inc.
OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit'' (PA-410A), midstream, no cups or droppers. Label reads: ''One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate.''
Terminated
LCXNone listed
Dec 3, 2004Chembio Diagnostic System Inc
OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal a
Terminated
LCXK933529
Dec 3, 2004Chembio Diagnostic System Inc
OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal
Terminated
LCXK961965

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