Cleared Traditional

QUANTIMETRIX SERUM ENZYME CONTROL

K880701 · Quantimetrix Corp. · Chemistry
Mar 1988
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K880701 is an FDA 510(k) clearance for the QUANTIMETRIX SERUM ENZYME CONTROL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on March 24, 1988, 31 days after receiving the submission on February 22, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K880701 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1988
Decision Date March 24, 1988
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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