510(k) K992452
- Device
- RAPIDONE-AMPHETAMINE TEST
- Applicant
- AMERICAN BIO MEDICA CORP.
- 510(k) number
- K992452
- Product code
- DOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-10-18
- Date received
- 1999-07-22
- Regulation
- 862.3100
- Classification name
- Gas Chromatography, Amphetamine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN B DUBECK
- Address
- 1001 G St., NW Suite 500 W. Washington DC US 20001 20001
FDA Registration Numbers#
- 3006198300
Source Documents#
Legacy Summary#
summary
FDA Review#
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