Cleared Traditional

K803095 - COPPER SULFATE SOLUTION SP. GR.1.055
(FDA 510(k) Clearance)

K803095 · Accra Laboratories, Inc. · Hematology
Mar 1981
Decision
88d
Days
Class 1
Risk

K803095 is an FDA 510(k) clearance for the COPPER SULFATE SOLUTION SP. GR.1.055, a Solution, Copper Sulfate For Specific Gravity Determinations (Class I — General Controls, product code KSL), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1981, 88 days after receiving the submission on December 8, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9320.

Submission Details

510(k) Number K803095 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1980
Decision Date March 06, 1981
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSL — Solution, Copper Sulfate For Specific Gravity Determinations
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.9320