Sun Biomedical Laboratories, Inc.
Blackwood, NJ, US
Sun Biomedical Laboratories, Inc. appears in FDA device records in Blackwood, NJ. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Sun Biomedical Laboratories, Inc. between 1994 and 2003. The busiest year on record is 1995, with 4. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023856 | VISUALINE METHADONE DIPSTRIPTEST | DJR | Substantially Equivalent | |
| K023648 | VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI | LDJ | Substantially Equivalent | |
| K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES | DIS | Substantially Equivalent | |
| K020136 | VISUALINE BARBITURATES DIPSTRIP TEST | DIS | Substantially Equivalent | |
| K011499 | VISUALINE AMPHETAMINE DIPSTRIP ASSAY | DKZ | Substantially Equivalent | |
| K010177 | VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY | DKZ | Substantially Equivalent | |
| K993485 | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE | DIO | Substantially Equivalent | |
| K983790 | VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE | LCM | Substantially Equivalent | |
| K981314 | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE | DJR | Substantially Equivalent | |
| K972032 | VISUALINE II METHAMPHETIMINE | DKZ | Substantially Equivalent | |
| K963606 | VISUALINE COMBO V (COCAINE/THC) TEST | LDJ | Substantially Equivalent | |
| K963408 | VISUALINE D HCG | JHI | Substantially Equivalent | |
| K953105 | VISUALINE II BENZODIAZEPINES | JXM | Substantially Equivalent | |
| K950445 | VISUALINE II CANNABINOIDS (THC) | LDJ | Substantially Equivalent | |
| K950369 | VISUALINE II COCAINE | DIO | Substantially Equivalent | |
| K943248 | VISUALINE II MORPHINE/OPIATES/HEROIN | DJG | Substantially Equivalent | |
| K943239 | VISUALINE II HCG | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1875-2008 | VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | Terminated | ||
| Z-1874-2008 | VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | Terminated | ||
| Z-1873-2008 | VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain