LCX · Class II · 21 CFR 862.1155

FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Leading manufacturers include Unipath , Ltd., ACON Laboratories, Inc. and Armkel, LLC.

226
Total
226
Cleared
104d
Avg days
1978
Since
226 devices
97–120 of 226
Cleared Mar 11, 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532
Phamatech
Chemistry · 28d
Cleared Jan 26, 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821
Quidel Corp.
Chemistry · 34d
Cleared Dec 19, 1997
SIGNAL PREGNANCY TEST KIT
K974021
Sa Scientific, Inc.
Chemistry · 58d
Cleared Dec 19, 1997
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154
Sa Scientific, Inc.
Chemistry · 45d
Cleared Oct 31, 1997
QUICK CARD HCG ONE STEP PREGNANCY TEST
K973570
Phamatech
Chemistry · 42d
Cleared Oct 27, 1997
BRAND NAME *1-STEP PREGNANCY
K973352
Armkel, LLC
Chemistry · 52d
Cleared Oct 20, 1997
FIRST SIGN
K973208
Texas Immunology, Inc.
Chemistry · 54d
Cleared Aug 01, 1997
QUICKSTICK ONE STEP HCG PREGNANCY TEST
K972682
Phamatech
Chemistry · 15d
Cleared May 08, 1997
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
K971286
Excel Scientific, Inc.
Chemistry · 31d
Cleared Mar 06, 1997
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
K970425
Excel Scientific, Inc.
Chemistry · 30d
Cleared Feb 18, 1997
ADVANCED QUALITY PREGNANCY TEST
K970008
Bionike, Inc.
Chemistry · 47d
Cleared Feb 04, 1997
PERFECTA PREGNANCY TEST
K965184
Wyntek Diagnostics, Inc.
Chemistry · 42d
Cleared Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082
Abbott Laboratories
Chemistry · 15d
Cleared Dec 02, 1996
MIDSTREAM ONESTEP PREGNANCY HOME TEST
K963341
Syntron Bioresearch, Inc.
Chemistry · 98d
Cleared Nov 18, 1996
FACT PLUS PREGNANCY TEST
K964108
Direct Access Diagnostics
Chemistry · 34d
Cleared Nov 07, 1996
NATURALE HCG PREGNANCY TES
K964002
Mizuho USA, Inc.
Chemistry · 31d
Cleared Oct 01, 1996
EVIDENCE PREGNANCY TEST
K962721
Saliva Diagnostic Systems
Chemistry · 78d
Cleared Sep 23, 1996
AFFIRM ONE-STEP HOME PREGNANCY TEST
K962888
Athena Medical Corp.
Chemistry · 61d
Cleared Aug 29, 1996
EZ SURE ONESTEP EARLY PREGNANCY TEST
K962580
Excel Scientific, Inc.
Chemistry · 59d
Cleared Jul 29, 1996
FACTPLUS ONE STEP PREGNANCY TEST
K962521
Direct Access Diagnostics
Chemistry · 40d
Cleared Jul 23, 1996
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219
Phamatech
Chemistry · 43d
Cleared Jul 10, 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
K962183
Armkel, LLC
Chemistry · 34d
Cleared Jun 24, 1996
SURE CHECK PREGNANCY TEST
K961965
Chembio Diagnostic Systems, Inc.
Chemistry · 35d
Cleared May 31, 1996
TBD AT-HOME PREGNANCY TEST
K961712
Armkel, LLC
Chemistry · 29d