Medical Device Manufacturer · US , Bethlehem , PA

OraSure Technologies, Inc. - FDA 510(k) Cleared Devices

30 submissions · 29 cleared · Since 1996

30

Total

29

Cleared

1

Denied

FDA 510(k) Regulatory Record - OraSure Technologies, Inc. Toxicology ✕

22 devices

1-12 of 22

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