Company ยท GB
Unipath , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2006. Name variants (Inc, Corp, punctuation) are merged.
73510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 20 |
| JTN | Susceptibility Test Discs, Antimicrobial | 10 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 |
| DCF | Albumin, Antigen, Antiserum, Control | 2 |
| GKZ | Counter, Differential Cell | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 |
| MSJ | Apolipoproteins | 2 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2006 | K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST Unipath , Ltd., GB | LCX |
| May 25, 2006 | K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Dec 6, 2005 | K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC Unipath , Ltd., GB | GTY |
| May 12, 2005 | K050930 | E.P.T. CERTAINTY PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Sep 10, 2004 | K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT Unipath , Ltd., GB | LCX |
| Jun 8, 2004 | K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Mar 8, 2004 | K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Mar 8, 2004 | K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Jan 16, 2004 | K033658 | E.P.T. PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Oct 20, 2003 | K032939 | EPT CERTAINTY PREGNANCY TEST Unipath , Ltd., GB | LCX |
| May 2, 2003 | K030659 | CLEARBLUE EASY DIGITAL PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Nov 27, 2002 | K023699 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Feb 19, 2002 | K013874 | CLEARPLANE EASY OVULATION TEST Unipath , Ltd. | CEP |
| Nov 9, 2001 | K013372 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST Unipath , Ltd. | LCX |
| Dec 16, 1999 | K993333 | CLEARPLAN EASY II HOME PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Dec 2, 1999 | K993703 | CLEARVIEW EASY HCG PREGNANCY TEST Unipath , Ltd., GB | JHI |
| Apr 7, 1999 | K990262 | CLEARPLAN EASY HOME PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Feb 24, 1999 | K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR Unipath , Ltd., GB | NGE |
| Dec 10, 1998 | K981946 | CLEARVIEW IM Unipath , Ltd., GB | KTN |
| Oct 28, 1998 | K981207 | CLEARPLAN EASY FERTILITY MONITOR Unipath , Ltd., GB | NGE |
| Jun 25, 1998 | K981271 | CLEARPLAN EASY OVULATION TEST Unipath , Ltd., GB | CEP |
| Feb 7, 1997 | K964495 | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 7, 1997 | K964492 | CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 7, 1997 | K964491 | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 7, 1997 | K964490 | AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 7, 1997 | K964489 | CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 7, 1997 | K964487 | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 6, 1997 | K964512 | CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 6, 1997 | K964501 | SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Feb 6, 1997 | K964496 | CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC Unipath , Ltd. | JTN |
| Feb 6, 1997 | K964493 | OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Unipath , Ltd. | JTN |
| Dec 16, 1996 | K962296 | STREPTOLEX-STAT Unipath , Ltd. | GTZ |
| Sep 13, 1996 | K955067 | CLEARVIEW C. DIFF A Unipath , Ltd., GB | MCB |
| Apr 29, 1996 | K960316 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| Jul 28, 1994 | K940557 | STAPHYTECT-OD Unipath , Ltd., GB | LHJ |
| Dec 29, 1993 | K934923 | CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET Unipath , Ltd., GB | JJX |
| Dec 29, 1993 | K934922 | CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET Unipath , Ltd., GB | JJX |
| May 11, 1993 | K924673 | CLEARVIEW HCG Unipath , Ltd., GB | JHI |
| Nov 22, 1991 | K913305 | CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER Unipath , Ltd. | GKZ |
| Oct 25, 1991 | K914240 | CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF Unipath , Ltd., GB | JHI |
| May 15, 1991 | K905741 | CLEARVIEW HCG SERUM/URINE Unipath , Ltd., GB | JHI |
| May 6, 1991 | K911566 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| Apr 1, 1991 | K910946 | CLEARVIEW HCG Unipath , Ltd., GB | JHJ |
| Feb 13, 1991 | K905742 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| Oct 4, 1990 | K903665 | CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY Unipath , Ltd. | GKZ |
| Sep 10, 1990 | K902892 | CELL-DYN CALIBRATOR Unipath , Ltd. | KRZ |
| Aug 22, 1990 | K902391 | CELL-DYN 3000 CONTROL Unipath , Ltd. | JCN |
| Jan 29, 1990 | K895280 | CLEARVIEW CHLAMYDIA Unipath , Ltd., GB | LJC |
| Oct 12, 1989 | K894579 | CLEARPLAN EASY Unipath , Ltd., GB | CEP |
| Jun 23, 1989 | K893422 | CLEARVIEW STREP A Unipath , Ltd., GB | GTZ |
Newest 50 of 73.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||