Cleared Traditional

K882101 - HEMOGLOBIN SCREENING DEVICE (FDA 510(k) Clearance)

Class I Hematology device.

K882101 · Portable Medical Laboratories, Inc. · Hematology device
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Jul 1988
Decision
51d
Days
Class 1
Risk

K882101 is an FDA 510(k) clearance for the HEMOGLOBIN SCREENING DEVICE. Classified as Solution, Copper Sulfate For Specific Gravity Determinations (product code KSL), Class I - General Controls.

Submitted by Portable Medical Laboratories, Inc. (Solana Beach, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 51 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 Portable Medical Laboratories, Inc. devices

Submission Details

510(k) Number K882101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1988
Decision Date July 01, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.