Cleared Traditional

K803095 - COPPER SULFATE SOLUTION SP. GR.1.055

K803095 is an FDA 510(k) clearance for COPPER SULFATE SOLUTION SP. GR.1.055, manufactured by Accra Laboratories, Inc.. The device is a Class 1 Hematology device with product code KSL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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

K803095 is an FDA 510(k) clearance for the COPPER SULFATE SOLUTION SP. GR.1.055. Classified as Solution, Copper Sulfate For Specific Gravity Determinations (product code KSL), Class I - General Controls.

Submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1981 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9320 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Accra Laboratories, Inc. devices

FDA 510(k) Submission Details - K803095

510(k) Number K803095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date March 06, 1981
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

KSL Device Classification - Class 1, General Controls

Product Code KSL Solution, Copper Sulfate For Specific Gravity Determinations
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.9320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.