Cleared Traditional

K791228 - PARA-8

K791228 is an FDA 510(k) clearance for PARA-8, 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 32-day FDA review.

K791228 · Streck Laboratories, Inc. · Hematology device
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Aug 1979
Decision
32d
Days
Class 2
Risk

K791228 is an FDA 510(k) clearance for the PARA-8. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 32 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K791228

510(k) Number K791228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1979
Decision Date August 03, 1979
Days to Decision 32 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
81d faster than avg
Panel avg: 113d · This submission: 32d
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 K791228.
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
K791772 · Diagnostic Technology, Inc. · Oct 1979
PLATELET-CHEX PLUS
K791226 · Streck Laboratories, Inc. · Aug 1979
PARA-7
K791227 · Streck Laboratories, Inc. · Aug 1979
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
K791030 · Beckman Instruments, Inc. · Jun 1979
COAGULATION ARP
K790826 · Helena Laboratories · May 1979
HEMOGLOBIN CONTROLS
K790457 · Data Medical Associates, Inc. · Apr 1979