Cleared Traditional

CHEMSTRIP L

K811189 · Biodynamics Corp. · Hematology
Jul 1981
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K811189 is an FDA 510(k) clearance for the CHEMSTRIP L, a Test, Leukocyte Alkaline Phosphatase (Class I — General Controls, product code GHD), submitted by Biodynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981, 89 days after receiving the submission on April 29, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7660.

Submission Details

510(k) Number K811189 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1981
Decision Date July 27, 1981
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHD — Test, Leukocyte Alkaline Phosphatase
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.7660