FDA 510(k) Applications Submitted by JANIS FREESTONE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970008 |
01/02/1997 |
ADVANCED QUALITY PREGNANCY TEST |
BIONIKE, INC. |
| K960992 |
03/12/1996 |
BIONIKE A/Q PREGNANCY TEST |
BIONIKE LABORATORIES, INC. |
| K990870 |
03/16/1999 |
REDI-TEST THC |
REDWOOD BIOTECH, INC. |
| K000979 |
03/27/2000 |
REDI-SCREEN |
REDWOOD BIOTECH, INC. |
| K010921 |
03/27/2001 |
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
| K991110 |
04/01/1999 |
REDI-TEST COCAINE |
REDWOOD BIOTECH, INC. |
| K981243 |
04/06/1998 |
BIOSTRIDE FREE T4 EIA TEST KIT |
BIOSTRIDE DIAGNOSTICS, INC. |
| K001126 |
04/07/2000 |
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST |
ALATEX SCIENTIFIC, INC. |
| K971361 |
04/11/1997 |
AQ OPIATES (MORPHINE) TEST |
BIONIKE LABORATORIES, INC. |
| K991504 |
04/29/1999 |
REDI-TEST METHAMPHETAMINE |
REDWOOD BIOTECH, INC. |
| K991698 |
05/18/1999 |
REDI-TEST PCP |
REDWOOD BIOTECH, INC. |
| K971841 |
05/19/1997 |
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST |
BIONIKE LABORATORIES, INC. |
| K001567 |
05/19/2000 |
ADVANTAGE THC TEST |
ADVANTAGE DIAGNOSTICS CORP. |
| K991883 |
06/02/1999 |
REDI-TEST OPIATES |
ADVANTAGE DIAGNOSTICS CORP. |
| K011962 |
06/22/2001 |
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
| K972384 |
06/26/1997 |
AQ ONE STEP COCAINE TEST |
BIONIKE LABORATORIES, INC. |
| K993100 |
09/16/1999 |
REDI-SCREEN |
REDWOOD BIOTECH, INC. |
| K023712 |
11/04/2002 |
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST |
ADVANTAGE DIAGNOSTICS CORP |
| K013778 |
11/13/2001 |
PEACE OF MIND HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
| K003708 |
12/01/2000 |
ADVANTAGE THC/COCAINE TEST |
ADVANTAGE DIAGNOSTICS CORP. |
| K994227 |
12/15/1999 |
ADVANTAGE HCG TEST (URINE/SERUM) |
ADVANTAGE DIAGNOSTICS CORP. |
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