EMIT D.A.U. AMPHETAMINE CLASS ASSAY

FDA 510(k) clearance K900995 · decided 1990-04-20

Clearance details

K-number: K900995
Device name: EMIT D.A.U. AMPHETAMINE CLASS ASSAY
Applicant: Syva Co.
Decision: Substantially Equivalent
Date received: 1990-03-01
Decision date: 1990-04-20
Days to decision: 50 days
Clearance type: Traditional
Product code: DKZ
Device class: 2
Regulation number: 862.3100
Medical specialty: Clinical Toxicology
Advisory committee: Clinical Toxicology
Location: Palo Alto, CA, US
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.