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ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) — Roche Diagnostic Systems, Inc. (510(k) K895906)

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) — Roche Diagnostic Systems, Inc. (510(k) K895906) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP); Applicant: Roche Diagnostic Systems, Inc.; Clearance track: 510(k).

Device nameABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
ApplicantRoche Diagnostic Systems, Inc.
Clearance track510(k)
Submission numberK895906
DecisionSubstantially Equivalent
Decision date1990-01-26
Date received1989-10-06
Product codeLCM
Device classU
Medical specialtyUnknown
Applicant locationNJ, US
SourceopenFDA device

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