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OraSure Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 29 products

Total Devices29
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K060859 COMPOUND W FREEZE OFF WART REMOVAL SYSTEMGEH2006-07-18 View
510(k) K023487 HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEGEH2003-03-20 View
510(k) K013882 OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IJXM2002-04-17 View
510(k) K020371 UPLINK TEST SYSTEMDJG2002-04-03 View
510(k) K011057 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXPJD2001-06-06 View
510(k) K002375 STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118ILDJ2001-01-26 View
510(k) K001976 STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108IDIS2000-12-06 View
510(k) K002010 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421DJR2000-11-29 View
510(k) K000399 STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541LCM2000-05-15 View
510(k) K001197 COCAINE METABOLITE INTERCEPT MICRO-PLATE EIADIO2000-05-11 View
510(k) K992918 STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103IDKZ2000-04-03 View
510(k) K993208 STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104ILAF2000-04-03 View
510(k) K990877 HISTOFREEZER DEVICEGEH1999-06-14 View
510(k) K982759 AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222UDIO1998-11-20 View
510(k) K982745 AUTO-LYTE BARBITURATES EIADIS1998-11-18 View
510(k) K982831 AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210UJXM1998-11-12 View
510(k) K982801 AUTO-LYTE PCP EIA, MODEL #1254ULCM1998-11-04 View
510(k) K982358 HISTOFREEZER DEVICEGEH1998-10-02 View
510(k) K982061 STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)DIO1998-08-25 View
510(k) K980739 HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARISGEH1998-05-26 View
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