OraSure Technologies, Inc. is one of 12929 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
OraSure Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: COMPOUND W FREEZE OFF WART REMOVAL SYSTEM, HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME, OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
30
Total
29
Cleared
1
Denied
OraSure Technologies, Inc. has 29 FDA 510(k) cleared toxicology devices. Based in Bethlehem, US.
Historical record: 29 cleared submissions from 1996 to 2006.
Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - OraSure Technologies, Inc.
30 devices
Not Cleared
Oct 10, 2019
OraQuick Ebola Rapid Antigen Test
Microbiology
150d
Cleared
Jul 18, 2006
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
General & Plastic Surgery
112d
Cleared
Mar 20, 2003
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
General & Plastic Surgery
154d
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