Atlas FDA

TENONE(TM) METHAMPHETAMINE

FDA 510(k) clearance K910043 · decided 1991-02-14

Clearance details

K-number
K910043
Device name
TENONE(TM) METHAMPHETAMINE
Applicant
Diagnostic Products Corp.
Decision
Substantially Equivalent
Date received
1991-01-04
Decision date
1991-02-14
Days to decision
41 days
Clearance type
Traditional
Product code
LAF
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Los Angeles, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.