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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 1995 | K954178 | OSOM PREGNANCY TEST Wyntek Diagnostics, Inc. | LCX |
| Oct 13, 1995 | K954364 | CAMEO HOME PREGNANCY TEST Quidel Corp. | LCX |
| Jul 19, 1995 | K950354 | HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY Ml Strategies, Inc. | LCX |
| Feb 10, 1995 | K945514 | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG Princeton BioMeditech Corp. | LCX |
| Jan 27, 1995 | K945846 | ADVANCE(R) PREGNANCY TEST Advanced Care Products | LCX |
| Jan 17, 1995 | K945568 | HCG MIDSTREAM PREGNANCY TEST Mizuho USA, Inc. | LCX |
| Oct 20, 1994 | K941765 | HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE Tcpi, Inc. | LCX |
| Jul 6, 1994 | K941771 | BODYWISE PREGNANCEY TEST Charlton Assoc. | LCX |
| Jul 6, 1994 | K941355 | PREGNANCY CHECK Sa Scientific, Inc. | LCX |
| Jun 2, 1994 | K940637 | PREDICTOR HOME PREGNANCY TEST Organon Teknika Corp. | LCX |
| May 19, 1994 | K933794 | ANI BIOCARD(TM) HCG TEST Canadian Bioclinical, Ltd., CA | LCX |
| Feb 25, 1994 | K936013 | EVATEST STRIP Boehringer Mannheim Italia Spa, IT | LCX |
| Feb 24, 1994 | K934516 | ADVANCE PREGNANCY TEST MODIFICATION Ortho Pharmaceutical Corp. | LCX |
| Dec 2, 1993 | K934830 | HCG PREGNANCY ONE STEP TEST STRIP Tcpi, Inc. | LCX |
| Sep 10, 1993 | K931997 | HCG MIDSTREAM PREGNANCY TEST Mizuho USA, Inc. | LCX |
| Apr 6, 1993 | K930488 | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST Syntron Bioresearch, Inc. | LCX |
| Mar 18, 1993 | K930640 | PRECISE PREGNANCY Bd Becton Dickinson Vacutainer Systems Preanalytic | LCX |
| Jan 26, 1993 | K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST Princeton Biomedix | LCX |
| Jan 6, 1993 | K925189 | PREGNAGEN 1-STEP PREGNANCY TEST Biogenex Laboratories | LCX |
| Dec 28, 1992 | K925096 | CONCEIVE ONE-STEP PREGNANCY TEST Quidel Corp. | LCX |
| May 29, 1992 | K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Apr 8, 1992 | K921012 | PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG Bd Becton Dickinson Vacutainer Systems Preanalytic | LCX |
| Dec 23, 1991 | K914990 | ADVANCE(R) PREGNANCY TEST Ortho Pharmaceutical Corp. | LCX |
| Oct 17, 1991 | K914304 | FIRST RESPONSE(R) ONE-STEP Armkel, LLC | LCX |
| Oct 17, 1991 | K914254 | HOMECLINIC ONE STEP PREGNANCY TEST Vanguard Biomedical Corp. | LCX |
| Jul 24, 1991 | K912316 | QUIKPAC-II ONE STEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| May 6, 1991 | K911566 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| Feb 13, 1991 | K905742 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| Dec 6, 1990 | K904782 | ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST Carter Products | LCX |
| Aug 2, 1990 | K901981 | ABBOTT MODIFIED FACT PLUS PREGNANCY TEST Abbott Laboratories | LCX |
| Mar 6, 1990 | K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT Pacific Biotech, Inc. | LCX |
| Nov 13, 1989 | K895560 | MODIFIED HOMECLINIC PREGNANCY TEST Vanguard Biomedical Corp. | LCX |
| Mar 8, 1989 | K884489 | C&T PREGNANCY TEST KIT Healthcheck Corp. | LCX |
| Jan 30, 1989 | K883430 | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST Disease Detection International, Inc. | LCX |
| Nov 29, 1988 | K883826 | HOME CLINIC PREGNANCY TEST Vanguard Biomedical Corp. | LCX |
| Oct 25, 1988 | K882232 | DISCOVER(R) Carter Products | LCX |
| Oct 6, 1988 | K882588 | BLUE DOT(TM) TEST FOR PREGNANCY V-Tech, Inc. | LCX |
| Jul 28, 1988 | K882416 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| May 16, 1988 | K880472 | ADVANCE* AND DAISY* PREGNANCY TEST Advanced Care Products | LCX |
| Apr 5, 1988 | K874823 | FIRST RESPONSE 5 MINUTE PREGNANCY TEST Tambrands, Inc. | LCX |
| Feb 11, 1988 | K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 Leeco Diagnostics, Inc. | LCX |
| Nov 4, 1987 | K874248 | SYNTRON BIORESEARCH U-TEST PREGNANCY TEST Syntron Bioresearch, Inc. | LCX |
| Aug 26, 1987 | K871601 | ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST Advanced Care Products | LCX |
| Aug 18, 1987 | K871996 | ABBOTT BIOTELL PREGNANCY TEST Abbott Laboratories | LCX |
| Jan 14, 1987 | K863341 | CARDS(TM) - EARLY PREGNANCY TEST Pacific Biotech, Inc. | LCX |
| Jan 9, 1987 | K864373 | CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) Unipath , Ltd., GB | LCX |
| Jan 9, 1987 | K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 Leeco Diagnostics, Inc. | LCX |
| Dec 22, 1986 | K863841 | TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE Hybritech, Inc. | LCX |
| Jun 17, 1986 | K862207 | QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION) Quidel Corp. | LCX |
| Jun 16, 1986 | K861946 | PTK PLUS. HOME PREGNANCY TEST Healthcheck Corp. | LCX |
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