STC Cannabinoids Micro-Plate Eia
FDA 510(k) K973750 · OraSure Technologies, Inc.
510(k) numberK973750
Submission
- Device name
- STC Cannabinoids Micro-Plate Eia
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- October 1, 1997
- Decision date
- February 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
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| K060859 | Compound W Freeze Off Wart Removal SystemGEH · Special | 07/18/2006SE |
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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 STC Cannabinoids Micro-Plate Eia cleared by the FDA?
STC Cannabinoids Micro-Plate Eia (K973750) received a 510(k) decision of Substantially Equivalent on February 13, 1998, 135 days after the submission was received.
What is the product code of K973750?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.