FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter
Leading manufacturers include Unipath , Ltd., Armkel, LLC and ACON Laboratories, Inc..
226
Total
226
Cleared
104d
Avg days
1978
Since
226 devices
Cleared
May 12, 2005
E.P.T. CERTAINTY PREGNANCY TEST
Unipath , Ltd.
Chemistry
28d
Cleared
Apr 25, 2005
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
Mizuho USA, Inc.
Chemistry
154d
Cleared
Apr 08, 2005
ONE STEP HCG URINE PREGNANCY TEST
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry
115d
Cleared
Oct 19, 2004
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
Armkel, LLC
Chemistry
200d
Cleared
Sep 10, 2004
FACT PLUS ONE-STEP PREGNANCY TEST KIT
Unipath , Ltd.
Chemistry
18d
Cleared
Sep 09, 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
ACON Laboratories, Inc.
Chemistry
31d
Cleared
Aug 09, 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
Azog, Inc.
Chemistry
41d
Cleared
Jun 08, 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
Unipath , Ltd.
Chemistry
13d
Cleared
May 20, 2004
ONE-STEP PREGNANCY TEST
W.H.P.M., Inc.
Chemistry
8d
Cleared
Mar 08, 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
Unipath , Ltd.
Chemistry
26d
Cleared
Mar 08, 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
Unipath , Ltd.
Chemistry
25d
Cleared
Jan 16, 2004
E.P.T. PREGNANCY TEST
Unipath , Ltd.
Chemistry
56d
Cleared
Nov 21, 2003
UNIMARK HOME PREGNANCY TEST DEVICE
Biotech Atlantic, Inc.
Chemistry
57d
Cleared
Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
ACON Laboratories, Inc.
Chemistry
53d
Cleared
Nov 12, 2003
GOOD MORNING TEST
Standard Diagnostics, Inc.
Chemistry
155d
Cleared
Oct 20, 2003
EPT CERTAINTY PREGNANCY TEST
Unipath , Ltd.
Chemistry
28d
Cleared
Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
ACON Laboratories, Inc.
Chemistry
47d
Cleared
Sep 22, 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
ACON Laboratories, Inc.
Chemistry
39d
Cleared
Sep 05, 2003
CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
Access Bio Incorporate
Chemistry
52d
Cleared
Jun 17, 2003
ONE-STEP PREGNANCY TEST
Amerisource Pharmacal, Inc.
Chemistry
56d
Cleared
May 02, 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
Unipath , Ltd.
Chemistry
60d
Cleared
Apr 17, 2003
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
Cenogenics Corp.
Chemistry
62d
Cleared
Apr 09, 2003
MID STREAM PREGNANCY TEST
Advanced Diagnostics, Inc.
Chemistry
209d
Cleared
Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
Armkel, LLC
Chemistry
32d