510(k) K913737
- Device
- Il Test(tm) Cocaine
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K913737
- Product code
- JXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-12-03
- Date received
- 1991-08-20
- Regulation
- 862.3250
- Classification name
- Enzyme Immunoassay, Cocaine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE A LYNA
- Address
- 180 Hartwell Rd. Bedford MA US 01730 01730
FDA Registration Numbers#
- 9610529
- 3013982035
- 9610126
- 3006198300
- 3003795116
Source Documents#
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 |
| K915785 | STC DIAGNOSTICS BENZOYLECGONINE EIA | Solarcare Technologies Corp,Inc. | 1992-03-11 |