Auto-Lyte Cotinine Eia
FDA 510(k) K972481 · OraSure Technologies, Inc.
510(k) numberK972481
Submission
- Device name
- Auto-Lyte Cotinine Eia
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- July 2, 1997
- Decision date
- October 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MKU – Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Specialty
- Clinical Toxicology
Other 510(k)s with product code MKU
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|---|---|---|---|
| K192517 | Psychemedics Microplate EIA for Cotinine in HairMKU · Traditional | Psychemedics Corporation | 04/22/2020SE |
| K192299 | LZI Cotinine II Enzyme ImmunoassayMKU · Traditional | Lin-Zhi International, Inc. | 11/21/2019SE |
| K062565 | Status DS Nicotine, Accusign Nicotine, Biosign NicotineMKU · Traditional | Princeton BioMeditech Corp. | 02/20/2007SE |
| K021944 | Cozart Eia Cotinine Urine KitMKU · Traditional | Cozart Bioscience , Ltd. | 05/14/2003SE |
| K974534 | Micro-Plate Cotinine EiaMKU · Traditional | OraSure Technologies, Inc. | 05/18/1998SE |
| K974234 | Micro-Plate Cotinine EiaMKU · Traditional | OraSure Technologies, Inc. | 05/14/1998SE |
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| K013882 | Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110IJXM · Traditional | 04/17/2002SE |
| K020371 | Uplink Test SystemDJG · Traditional | 04/03/2002SE |
| K011057 | Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXPJD · Traditional | 06/06/2001SE |
| K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118ILDJ · Traditional | 01/26/2001SE |
| K001976 | STC Barbiturates Intercept Micro-Plate Eia, Model 1108IDIS · Traditional | 12/06/2000SE |
| K002010 | STC Methadone Intercept Micro-Plate Eia, Model 11421DJR · Traditional | 11/29/2000SE |
| K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541LCM · Traditional | 05/15/2000SE |
| K001197 | Cocaine Metabolite Intercept Micro-Plate EiaDIO · Special | 05/11/2000SE |
Questions and answers
When was Auto-Lyte Cotinine Eia cleared by the FDA?
Auto-Lyte Cotinine Eia (K972481) received a 510(k) decision of Substantially Equivalent on October 21, 1997, 111 days after the submission was received.
What is the product code of K972481?
The FDA product code is MKU – Enzyme Immunoassay, Nicotine And Nicotine Metabolites, a Class I (low risk) device regulated under 21 CFR 862.3220.