Cleared Traditional

BCD-HPP41C INTERFACE

K810968 · Dynatech Corp. · Immunology
Apr 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K810968 is an FDA 510(k) clearance for the BCD-HPP41C INTERFACE, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 14 days after receiving the submission on April 9, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K810968 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1981
Decision Date April 23, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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