Cleared Traditional

K933844 - PARA 4 PLUS

K933844 is an FDA 510(k) clearance for PARA 4 PLUS, manufactured by Streck Laboratories, Inc.. The device is a Class 1 Hematology device with product code JJY cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K933844 · Streck Laboratories, Inc. · Hematology device
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Dec 1993
Decision
143d
Days
Class 1
Risk

K933844 is an FDA 510(k) clearance for the PARA 4 PLUS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck Laboratories, Inc. devices

FDA 510(k) Submission Details - K933844

510(k) Number K933844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1993
Decision Date December 27, 1993
Days to Decision 143 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 113d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

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