Cleared Traditional

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)

K902575 · Diagnostic Products Corp. · Chemistry
Oct 1990
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K902575 is an FDA 510(k) clearance for the SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL), a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 4, 1990, 115 days after receiving the submission on June 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K902575 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1990
Decision Date October 04, 1990
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIW — Calibrator, Surrogate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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