AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
FDA 510(k) clearance K923314 · decided 1992-08-24
Clearance details
- K-number
- K923314
- Device name
- AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
- Applicant
- Serex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-07
- Decision date
- 1992-08-24
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JXO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Maywood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (K201228) | Psychemedics Corporation | 2021-06-25 |
| PSYCHEMEDICS COCAINE EIA (K111925) | Psychemedics Corp. | 2012-05-01 |
| STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (K921140) | Solarcare Technologies Corp,Inc. | 1992-08-20 |
| STC DIAGNOSTICS BENZOYLECGONINE EIA (K915785) | Solarcare Technologies Corp,Inc. | 1992-03-11 |
| IL TEST(TM) COCAINE (K913737) | Instrumentation Laboratory CO | 1991-12-03 |
Recalls involving this device
No recalls on record reference this clearance.