Cleared Traditional

K841531 - PARA-TEK

K841531 is an FDA 510(k) clearance for PARA-TEK, manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K841531 · Streck Laboratories, Inc. · Hematology device
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Jul 1984
Decision
102d
Days
Class 2
Risk

K841531 is an FDA 510(k) clearance for the PARA-TEK. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 - K841531

510(k) Number K841531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1984
Decision Date July 27, 1984
Days to Decision 102 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 113d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K841531.
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · R&D Systems, Inc. · Nov 1984
RETIC-CHEX
K843093 · Streck Laboratories, Inc. · Oct 1984
DIA T1, T2 & T3
K842286 · Diatech, Inc. · Sep 1984
TECHNICON TEST POINT ASSAYED HEMATOLOGY
K842109 · Technicon Instruments Corp. · Jul 1984
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
K842440 · Anco Medical Reagents & Assoc. · Jul 1984
PARA 4
K842017 · Streck Laboratories, Inc. · Jun 1984