Cleared Traditional

K772105 - PLATELET KIT (FDA 510(k) Clearance)

Class I Hematology device.

K772105 · Streck Laboratories, Inc. · Hematology device
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Nov 1977
Decision
23d
Days
Class 1
Risk

K772105 is an FDA 510(k) clearance for the PLATELET KIT. Classified as Platelet Counting, Manual (product code GLG), Class I - General Controls.

Submitted by Streck Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1977 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6160 - 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 Streck Laboratories, Inc. devices

Submission Details

510(k) Number K772105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1977
Decision Date November 30, 1977
Days to Decision 23 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 113d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GLG Platelet Counting, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
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.