Cleared Traditional

ERYTHOCYTE CREATINE (K852767) - FDA 510(k) Clearance

Class I Hematology device.

K852767 · Panmed, Inc. · Hematology device
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Nov 1986
Decision
503d
Days
Class 1
Risk

K852767 is an FDA 510(k) clearance for the ERYTHOCYTE CREATINE. Classified as Conversion To Creatinine, Creatine (product code JLA), Class I - General Controls.

Submitted by Panmed, Inc. (Three Oaks, US). The FDA issued a Cleared decision on November 13, 1986 after a review of 503 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1210 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Panmed, Inc. devices

Submission Details

510(k) Number K852767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1985
Decision Date November 13, 1986
Days to Decision 503 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
390d slower than avg
Panel avg: 113d · This submission: 503d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLA Conversion To Creatinine, Creatine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1210
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.