Advantage Diagnostics Corp.
Redwood City, CA, US
Advantage Diagnostics Corp. appears in FDA device records in Redwood City, CA. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Advantage Diagnostics Corp. between 1988 and 2003. The busiest year on record is 2001, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1990 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023712 | ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST | DKZ | Substantially Equivalent | |
| K013778 | PEACE OF MIND HOME DRUG TEST | MVO | Substantially Equivalent | |
| K011962 | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST | DIO | Substantially Equivalent | |
| K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST | LDJ | Substantially Equivalent | |
| K003708 | ADVANTAGE THC/COCAINE TEST | DIO | Substantially Equivalent | |
| K001567 | ADVANTAGE THC TEST | LDJ | Substantially Equivalent | |
| K994227 | ADVANTAGE HCG TEST (URINE/SERUM) | JHI | Substantially Equivalent | |
| K991883 | REDI-TEST OPIATES | DJG | Substantially Equivalent | |
| K903416 | CANNULA, SURGICAL | GEA | Substantially Equivalent | |
| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | LXQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GEACannula, Surgical, General & Plastic Surgery
- LXQCup, Eye
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The Counter
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain