Cleared Traditional

K780785 - DILUTOR TRANSPORTER
(FDA 510(k) Clearance)

Jun 1978
Decision
33d
Days
Class 1
Risk

K780785 is an FDA 510(k) clearance for the DILUTOR TRANSPORTER. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978, 33 days after receiving the submission on May 12, 1978.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K780785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1978
Decision Date June 14, 1978
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2750

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