STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
FDA 510(k) clearance K002375 · decided 2001-01-26
Clearance details
- K-number
- K002375
- Device name
- STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
- Applicant
- OraSure Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-04
- Decision date
- 2001-01-26
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- LDJ
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Pl recall (Z-0477-2009) | OraSure Technologies, Inc. | 2008-12-23 |
| Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Pl recall (Z-0478-2009) | OraSure Technologies, Inc. | 2008-12-23 |
| Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro P recall (Z-0479-2009) | OraSure Technologies, Inc. | 2008-12-23 |
| Cannabinoids Intercept Micro Plate EIA 100 plate kit recall (Z-0481-2009) | OraSure Technologies, Inc. | 2008-12-18 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OraQuick HCV Rapid Antibody Test (P080027/S039) | OraSure Technologies, Inc. | 2021-04-20 |
| OraQuick HCV Rapid Antibody Test (P080027/S038) | OraSure Technologies, Inc. | 2021-02-25 |
| OraQuick HCV Rapid Antibody Test (P080027/S037) | OraSure Technologies, Inc. | 2020-10-16 |
| OraQuick HCV Rapid Antibody Test (P080027/S035) | OraSure Technologies, Inc. | 2019-09-11 |
| OraQuick HCV Rapid Antibody Test (P080027/S034) | OraSure Technologies, Inc. | 2018-12-06 |
| OraQuick HCV Rapid Antibody Test (P080027/S033) | OraSure Technologies, Inc. | 2018-04-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S032) | OraSure Technologies, Inc. | 2018-02-01 |
| OraQuick HCV Rapid Antibody Test (P080027/S031) | OraSure Technologies, Inc. | 2018-01-03 |