510(k) K915785
- Device
- STC DIAGNOSTICS BENZOYLECGONINE EIA
- Applicant
- SOLARCARE TECHNOLOGIES CORP,INC.
- 510(k) number
- K915785
- Product code
- JXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-11
- Date received
- 1991-12-24
- Regulation
- 862.3250
- Classification name
- Enzyme Immunoassay, Cocaine
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAM NIEDBALA
- Address
- Ben Franklin Technology Center 115 Research Dr. Bethlehem PA US 18015 18015
FDA Registration Numbers#
- 9610529
- 3013982035
- 9610126
- 3006198300
- 3003795116
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | Psychemedics Corporation | 2021-06-25 |
| K111925 | PSYCHEMEDICS COCAINE EIA | Psychemedics Corp. | 2012-05-01 |
| K923314 | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | Serex, Inc. | 1992-08-24 |
| K921140 | STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA | Solarcare Technologies Corp,Inc. | 1992-08-20 |
| K913737 | IL TEST(TM) COCAINE | Instrumentation Laboratory CO | 1991-12-03 |
Legacy Summary#
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FDA Review#
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