Cleared Traditional

K823794 - CONTROL TM 8

K823794 is an FDA 510(k) clearance for CONTROL TM 8, manufactured by General Diagnostics. The device is a Class 2 Hematology device with product code GLQ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K823794 · General Diagnostics · Hematology device
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Jan 1983
Decision
29d
Days
Class 2
Risk

K823794 is an FDA 510(k) clearance for the CONTROL TM 8. Classified as Mixture, Control, White-cell And Red-cell Indices (product code GLQ), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 29 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.

FDA 510(k) Submission Details - K823794

510(k) Number K823794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1982
Decision Date January 14, 1983
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GLQ Device Classification - Class 2, Special Controls

Product Code GLQ Mixture, Control, White-cell And Red-cell Indices
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 - GLQ Mixture, Control, White-cell And Red-cell Indices

All 9
Devices cleared under the same product code (GLQ) and FDA review panel - the closest regulatory comparables to K823794.
PARA 12 PLUS RETICS
K000945 · Streck Laboratories, Inc. · Apr 2000
XE CHECK
K994388 · Streck Laboratories, Inc. · Jan 2000
STAK-CHEX PLUS RETICS
K992887 · Streck Laboratories, Inc. · Nov 1999
UNI-CELL
K823587 · Medical Specialties Laboratories · Jan 1983
PARA 12
K823498 · Streck Laboratories, Inc. · Dec 1982
K823794 · CONTROL TM 8
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