510(k) K990409
- Device
- ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K990409
- Product code
- DMY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-04-15
- Date received
- 1999-02-09
- Regulation
- 862.3640
- Classification name
- Gas Chromatography, Morphine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER L TRIBBETT
- Address
- 9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250
Source Documents#
Legacy Summary#
summary
FDA Review#
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