Cleared Traditional

K761183 - LYSING AGENT AF

K761183 is an FDA 510(k) clearance for LYSING AGENT AF, manufactured by Central Labs. Assoc. MD Pathologists. The device is a Class 1 Pathology device with product code JCE cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K761183 · Central Labs. Assoc. MD Pathologists · Pathology device
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Jan 1977
Decision
46d
Days
Class 1
Risk

K761183 is an FDA 510(k) clearance for the LYSING AGENT AF. Classified as Solution, Isotonic (product code JCE), Class I - General Controls.

Submitted by Central Labs. Assoc. MD Pathologists (Mchenry, US). The FDA issued a Cleared decision on January 17, 1977 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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.

FDA 510(k) Submission Details - K761183

510(k) Number K761183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1976
Decision Date January 17, 1977
Days to Decision 46 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 78d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

JCE Device Classification - Class 1, General Controls

Product Code JCE Solution, Isotonic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.

Regulatory Peers - JCE Solution, Isotonic

Devices cleared under the same product code (JCE) and FDA review panel - the closest regulatory comparables to K761183.
IMMUNOHEMATOLOGICAL SALINE #97139
K831200 · Emd Chemicals, Inc. · May 1983
CERTIFIED BLOOD BANK SALINE
K801506 · Nobel Scientific Industries, Inc. · Jul 1980
COUITER/CMS ISOTONIC BLOOD BANK SALINE
K792101 · Coulter Electronics, Inc. · Nov 1979
BARBITAL SALINE BUFFER
K761170 · Bio/Data Corp. · Jan 1977
PHYSIOLOGIC SALINE (0.85%)
K761174 · Bio/Data Corp. · Jan 1977
K761183 · LYSING AGENT AF
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