OraSure Technologies, Inc. - FDA 510(k) Cleared Devices
30
Total
29
Cleared
1
Denied
22 devices
Cleared
Apr 17, 2002
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
Toxicology
145d
Cleared
Apr 03, 2002
UPLINK TEST SYSTEM
Toxicology
58d
Cleared
Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
Toxicology
61d
Cleared
Jan 26, 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
Toxicology
175d
Cleared
Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
Toxicology
160d
Cleared
Nov 29, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
Toxicology
149d
Cleared
May 15, 2000
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
Toxicology
98d
Cleared
May 11, 2000
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
Toxicology
30d
Cleared
Apr 03, 2000
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
Toxicology
217d
Cleared
Apr 03, 2000
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
Toxicology
192d
Cleared
Nov 20, 1998
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
Toxicology
106d
Cleared
Nov 18, 1998
AUTO-LYTE BARBITURATES EIA
Toxicology
104d
Cleared
Nov 12, 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
Toxicology
93d
Cleared
Nov 04, 1998
AUTO-LYTE PCP EIA, MODEL #1254U
Toxicology
86d
Cleared
Aug 25, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
Toxicology
82d
Cleared
May 22, 1998
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
Toxicology
39d
Cleared
May 18, 1998
MICRO-PLATE COTININE EIA
Toxicology
167d
Cleared
May 14, 1998
MICRO-PLATE COTININE EIA
Toxicology
183d
Cleared
Feb 13, 1998
STC CANNABINOIDS MICRO-PLATE EIA
Toxicology
135d
Cleared
Jan 28, 1998
STC METHAMPHETAMINE MICRO-PLATE EIA
Toxicology
169d
Cleared
Jan 02, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA
Toxicology
99d
Cleared
Oct 21, 1997
AUTO-LYTE COTININE EIA
Toxicology
111d