Company ยท US
Advantage Diagnostics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2003. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| LXQ | Cup, Eye | 1 |
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2003 | K023712 | ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST Advantage Diagnostics Corp. | DKZ |
| Feb 7, 2002 | K013778 | PEACE OF MIND HOME DRUG TEST Advantage Diagnostics Corp. | MVO |
| Aug 9, 2001 | K011962 | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST Advantage Diagnostics Corp., GB | DIO |
| Jun 25, 2001 | K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST Advantage Diagnostics Corp. | LDJ |
| Jan 22, 2001 | K003708 | ADVANTAGE THC/COCAINE TEST Advantage Diagnostics Corp. | DIO |
| Jun 19, 2000 | K001567 | ADVANTAGE THC TEST Advantage Diagnostics Corp. | LDJ |
| Feb 3, 2000 | K994227 | ADVANTAGE HCG TEST (URINE/SERUM) Advantage Diagnostics Corp. | JHI |
| Sep 15, 1999 | K991883 | REDI-TEST OPIATES Advantage Diagnostics Corp. | DJG |
| Nov 23, 1990 | K903416 | CANNULA, SURGICAL Advantage Diagnostics Corp. | GEA |
| May 13, 1988 | K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP Advantage Diagnostics Corp. | LXQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||