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)
Top companies in LCX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2026 | GOLD STAR DISTRIBUTION INC PREGNANCY TEST 24CT Open, Classified |
LCX | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Pregnancy Test Open, Classified |
LCX | None listed |
| Nov 7, 2023 | Family Dollar Stores, Llc. FIRST RESPONSE 2 CT, SKU 902343 Open, Classified |
LCX | K123436 |
| Nov 7, 2023 | Family Dollar Stores, Llc. VERIQUICK PREGNANCY TEST 1CT, SKU 901260 Open, Classified |
LCX | K123703 |
| Nov 7, 2023 | Family Dollar Stores, Llc. CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 Open, Classified |
LCX | K200913 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS Pregnancy Test Midstream REF 100-17 Open, Classified |
LCX | K974059 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Open, Classified |
LCX | K974059 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Open, Classified |
LCX | K110889 |
| Oct 23, 2023 | Universal Meditech Inc. Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Open, Classified |
LCX | K974059 |
| Oct 23, 2023 | Universal Meditech Inc. One Step Pregnancy Test REF 100-01 Open, Classified |
LCX | K110889 |
| Apr 7, 2023 | Church & 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 |
LCX | K083716 |
| Aug 17, 2022 | Family Dollar Stores, Llc. FIRST RESPONSE 2 CT, SKU 902343 Open, Classified |
LCX | K123436 |
| Aug 17, 2022 | Family Dollar Stores, Llc. Veriquick Pregnancy Test 2CT, SKU 903756 Open, Classified |
LCX | K123703 |
| Aug 17, 2022 | Family Dollar Stores, Llc. VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504 Open, Classified |
LCX | K123703 |
| Aug 17, 2022 | Family Dollar Stores, Llc. CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260 Open, Classified |
LCX | K200913 |
| Sep 25, 2010 | Inverness 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 |
LCX | None listed |
| Sep 25, 2010 | Inverness 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 |
LCX | None listed |
| Mar 8, 2010 | Mainline Technology, Inc. Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C.
The product is used as a pregnancy test. Terminated |
LCX | None listed |
| Jan 5, 2007 | Mizuho 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 |
LCX | K060825 |
| Jul 22, 2005 | Core 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 |
LCX | None listed |
| Jun 21, 2005 | Harmony 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 |
LCX | None listed |
| Jan 28, 2005 | International 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 |
LCX | None listed |
| Jan 28, 2005 | International 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 |
LCX | None listed |
| Dec 3, 2004 | Chembio 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 |
LCX | K933529 |
| Dec 3, 2004 | Chembio 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 |
LCX | K961965 |
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