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ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST — Acon Laboratories Co. (510(k) K980736)

ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST — Acon Laboratories Co. (510(k) K980736) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST; Applicant: Acon Laboratories Co.; Clearance track: 510(k).

Device nameACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
ApplicantAcon Laboratories Co.
Clearance track510(k)
Submission numberK980736
DecisionSubstantially Equivalent
Decision date1998-04-16
Date received1998-02-25
Product codeJHI
Device class2
Medical specialtyClinical Chemistry
Applicant locationPA, US
SourceopenFDA device

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