FDA 510(k) Applications Submitted by ORASURE TECHNOLOGIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K971392 |
04/15/1997 |
HISTOFREEZER VERRUCA PLANA |
ORASURE TECHNOLOGIES, INC. |
| K962435 |
06/24/1996 |
STC AUTO-LYTE URINARY GLUCOSE ASSAY |
ORASURE TECHNOLOGIES, INC. |
| K981341 |
04/13/1998 |
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) |
ORASURE TECHNOLOGIES, INC. |
| K974534 |
12/02/1997 |
MICRO-PLATE COTININE EIA |
ORASURE TECHNOLOGIES, INC. |
| K000399 |
02/07/2000 |
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 |
ORASURE TECHNOLOGIES, INC. |
| K020371 |
02/04/2002 |
UPLINK TEST SYSTEM |
ORASURE TECHNOLOGIES, INC. |
| K980739 |
02/25/1998 |
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS |
ORASURE TECHNOLOGIES, INC. |
| K990877 |
03/16/1999 |
HISTOFREEZER DEVICE |
ORASURE TECHNOLOGIES, INC. |
| K001197 |
04/11/2000 |
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
| K001976 |
06/29/2000 |
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I |
ORASURE TECHNOLOGIES, INC. |
| K002010 |
07/03/2000 |
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 |
ORASURE TECHNOLOGIES, INC. |
| K002375 |
08/04/2000 |
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I |
ORASURE TECHNOLOGIES, INC. |
| K982745 |
08/06/1998 |
AUTO-LYTE BARBITURATES EIA |
ORASURE TECHNOLOGIES, INC. |
| K982759 |
08/06/1998 |
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U |
ORASURE TECHNOLOGIES, INC. |
| K982831 |
08/11/1998 |
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U |
ORASURE TECHNOLOGIES, INC. |
| K972989 |
08/12/1997 |
STC METHAMPHETAMINE MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
| K992918 |
08/30/1999 |
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I |
ORASURE TECHNOLOGIES, INC. |
| K993208 |
09/24/1999 |
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I |
ORASURE TECHNOLOGIES, INC. |
| K973651 |
09/25/1997 |
STC COCAINE METABOLITE MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
| K973750 |
10/01/1997 |
STC CANNABINOIDS MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
| K023487 |
10/17/2002 |
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME |
ORASURE TECHNOLOGIES, INC. |
| K013882 |
11/23/2001 |
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I |
ORASURE TECHNOLOGIES, INC. |
| K011057 |
04/06/2001 |
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX |
ORASURE TECHNOLOGIES, INC. |
| K982358 |
07/06/1998 |
HISTOFREEZER DEVICE |
ORASURE TECHNOLOGIES, INC. |
| K982801 |
08/10/1998 |
AUTO-LYTE PCP EIA, MODEL #1254U |
ORASURE TECHNOLOGIES, INC. |
| K982061 |
06/04/1998 |
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) |
ORASURE TECHNOLOGIES, INC. |
| K972481 |
07/02/1997 |
AUTO-LYTE COTININE EIA |
ORASURE TECHNOLOGIES, INC. |
| K974234 |
11/12/1997 |
MICRO-PLATE COTININE EIA |
ORASURE TECHNOLOGIES, INC. |
| K060859 |
03/28/2006 |
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM |
ORASURE TECHNOLOGIES, INC. |
| DEN190025 |
05/13/2019 |
OraQuick Ebola Rapid Antigen Test |
OraSure Technologies, Inc. |
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