Bionike Laboratories, Inc. is one of 13072 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bionike Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BIONIKE AQ PHENCYCLIDINE (PCP) TEST, AQ ONE STEP COCAINE TEST, BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
6
Total
6
Cleared
0
Denied
Bionike Laboratories, Inc. has 6 FDA 510(k) cleared medical devices. Based in Sunnyvale, US.
Historical record: 6 cleared submissions from 1995 to 1999. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Bionike Laboratories, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by California Department of Health Services as regulatory consultant.
FDA 510(k) Regulatory Record - Bionike Laboratories, Inc.
6 devices
Cleared
Dec 07, 1999
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
Toxicology
18d
Cleared
Aug 06, 1997
AQ ONE STEP COCAINE TEST
Toxicology
41d
Cleared
Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
Toxicology
37d
Cleared
Jun 06, 1997
AQ OPIATES (MORPHINE) TEST
Toxicology
56d
Cleared
Apr 25, 1996
BIONIKE A/Q PREGNANCY TEST
Chemistry
44d
Cleared
Dec 11, 1995
BIONIKE A/Q PREGNANCY TEST
Chemistry
47d