Cleared Traditional

TECH-CAL(TM)/MULTIPLE

K881161 · R&D Systems, Inc. · Hematology
May 1988
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K881161 is an FDA 510(k) clearance for the TECH-CAL(TM)/MULTIPLE, a Calibrator For Red-cell And White-cell Counting (Class II — Special Controls, product code KSA), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 2, 1988, 45 days after receiving the submission on March 18, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K881161 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1988
Decision Date May 02, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSA — Calibrator For Red-cell And White-cell Counting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8185

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