Company ยท US
Sun Biomedical Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2003. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2003 | K023856 | VISUALINE METHADONE DIPSTRIPTEST Sun Biomedical Laboratories, Inc. | DJR |
| May 6, 2003 | K023648 | VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI Sun Biomedical Laboratories, Inc. | LDJ |
| Apr 25, 2002 | K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES Sun Biomedical Laboratories, Inc. | DIS |
| Mar 20, 2002 | K020136 | VISUALINE BARBITURATES DIPSTRIP TEST Sun Biomedical Laboratories, Inc. | DIS |
| Jul 17, 2001 | K011499 | VISUALINE AMPHETAMINE DIPSTRIP ASSAY Sun Biomedical Laboratories, Inc. | DKZ |
| May 17, 2001 | K010177 | VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY Sun Biomedical Laboratories, Inc. | DKZ |
| Dec 27, 1999 | K993485 | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE Sun Biomedical Laboratories, Inc. | DIO |
| Mar 1, 1999 | K983790 | VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE Sun Biomedical Laboratories, Inc. | LCM |
| Sep 4, 1998 | K981314 | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE Sun Biomedical Laboratories, Inc. | DJR |
| Aug 12, 1997 | K972032 | VISUALINE II METHAMPHETIMINE Sun Biomedical Laboratories, Inc. | DKZ |
| Oct 30, 1996 | K963606 | VISUALINE COMBO V (COCAINE/THC) TEST Sun Biomedical Laboratories, Inc. | LDJ |
| Oct 18, 1996 | K963408 | VISUALINE D HCG Sun Biomedical Laboratories, Inc. | JHI |
| Oct 5, 1995 | K953105 | VISUALINE II BENZODIAZEPINES Sun Biomedical Laboratories, Inc. | JXM |
| May 2, 1995 | K950445 | VISUALINE II CANNABINOIDS (THC) Sun Biomedical Laboratories, Inc. | LDJ |
| Mar 21, 1995 | K950369 | VISUALINE II COCAINE Sun Biomedical Laboratories, Inc. | DIO |
| Jan 30, 1995 | K943248 | VISUALINE II MORPHINE/OPIATES/HEROIN Sun Biomedical Laboratories, Inc. | DJG |
| Dec 7, 1994 | K943239 | VISUALINE II HCG Sun Biomedical Laboratories, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Sun Biomedical Laboratories, Inc. 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);
Terminated |
DJR | None listed |
| Sep 17, 2008 | Sun Biomedical Laboratories, Inc. VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Terminated |
JXN | None listed |
| Sep 17, 2008 | Sun Biomedical Laboratories, Inc. VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Terminated |
DJR | None listed |