Unipath, Ltd.
New York, NY, US
Unipath , Ltd. appears in FDA device records in New York, NY. FDA records list 73 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 73
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 73FDA records hold 73 510(k) clearances for Unipath, Ltd. between 1986 and 2006. The busiest year on record is 1987, with 14. The most recent is 2006, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 14 |
| 1988 | 6 |
| 1989 | 4 |
| 1990 | 4 |
| 1991 | 6 |
| 1993 | 3 |
| 1994 | 1 |
| 1996 | 3 |
| 1997 | 10 |
| 1998 | 3 |
| 1999 | 4 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 5 |
| 2005 | 2 |
| 2006 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | LCX | Substantially Equivalent | |
| K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | GTY | Substantially Equivalent | |
| K050930 | E.P.T. CERTAINTY PREGNANCY TEST | LCX | Substantially Equivalent | |
| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | LCX | Substantially Equivalent | |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | LCX | Substantially Equivalent | |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | LCX | Substantially Equivalent | |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | LCX | Substantially Equivalent | |
| K033658 | E.P.T. PREGNANCY TEST | LCX | Substantially Equivalent | |
| K032939 | EPT CERTAINTY PREGNANCY TEST | LCX | Substantially Equivalent | |
| K030659 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | |
| K023699 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | LCX | Substantially Equivalent | |
| K013874 | CLEARPLANE EASY OVULATION TEST | CEP | Substantially Equivalent | |
| K013372 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | LCX | Substantially Equivalent | |
| K993333 | CLEARPLAN EASY II HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K993703 | CLEARVIEW EASY HCG PREGNANCY TEST | JHI | Substantially Equivalent | |
| K990262 | CLEARPLAN EASY HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | NGE | Substantially Equivalent | |
| K981946 | CLEARVIEW IM | KTN | Substantially Equivalent | |
| K981207 | CLEARPLAN EASY FERTILITY MONITOR | NGE | Substantially Equivalent | |
| K981271 | CLEARPLAN EASY OVULATION TEST | CEP | Substantially Equivalent | |
| K964495 | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964492 | CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964491 | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964490 | AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964489 | CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964487 | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964512 | CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964501 | SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K964496 | CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC | JTN | Substantially Equivalent | |
| K964493 | OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | Substantially Equivalent | |
| K962296 | STREPTOLEX-STAT | GTZ | Substantially Equivalent | |
| K955067 | CLEARVIEW C. DIFF A | MCB | Substantially Equivalent | |
| K960316 | CLEARBLUE EASY | LCX | Substantially Equivalent | |
| K940557 | STAPHYTECT-OD | LHJ | Substantially Equivalent | |
| K934923 | CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET | JJX | Substantially Equivalent | |
| K934922 | CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET | JJX | Substantially Equivalent | |
| K924673 | CLEARVIEW HCG | JHI | Substantially Equivalent | |
| K913305 | CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER | GKZ | Substantially Equivalent | |
| K914240 | CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF | JHI | Substantially Equivalent | |
| K905741 | CLEARVIEW HCG SERUM/URINE | JHI | Substantially Equivalent | |
| K911566 | CLEARBLUE EASY | LCX | Substantially Equivalent | |
| K910946 | CLEARVIEW HCG | JHJ | Substantially Equivalent | |
| K905742 | CLEARBLUE EASY | LCX | Substantially Equivalent | |
| K903665 | CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY | GKZ | Substantially Equivalent | |
| K902892 | CELL-DYN CALIBRATOR | KRZ | Substantially Equivalent | |
| K902391 | CELL-DYN 3000 CONTROL | JCN | Substantially Equivalent | |
| K895280 | CLEARVIEW CHLAMYDIA | LJC | Substantially Equivalent | |
| K894579 | CLEARPLAN EASY | CEP | Substantially Equivalent | |
| K893422 | CLEARVIEW STREP A | GTZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DCFAlbumin, Antigen, Antiserum, Control
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- MCBAntigen, C. Difficile
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- JBQAntithrombin Iii Quantitation
- MSJApolipoproteins
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- CZWComplement C3, Antigen, Antiserum, Control
- JCNControl, Cell Counter, Normal And Abnormal
- GKZCounter, Differential Cell
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LERFluorescent Immunoassay, Theophylline
- DADHaptoglobin, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JZWNephelometer
- CEPRadioimmunoassay, Luteinizing Hormone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- LHJStaphylococcus Aureus Protein A Insoluble
- JTNSusceptibility Test Discs, Antimicrobial
- KQJSystem, Fibrinogen Determination
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- DDGTransferrin, Antigen, Antiserum, Control
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain