Cleared Traditional

RE-CELL SLIDE RECAP

K772139 · Geometric Data, Div. Smithkline Corp. · Hematology
Jan 1978
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K772139 is an FDA 510(k) clearance for the RE-CELL SLIDE RECAP, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1978, 52 days after receiving the submission on November 14, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K772139 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1977
Decision Date January 05, 1978
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JOY — Device, Automated Cell-locating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260

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