Cleared Traditional

K920997 - CD-CHEX

K920997 is an FDA 510(k) clearance for CD-CHEX, manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with product code GGL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920997 · Streck Laboratories, Inc. · Hematology device
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May 1992
Decision
90d
Days
Class 2
Risk

K920997 is an FDA 510(k) clearance for the CD-CHEX. Classified as Control, White-cell (product code GGL), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on May 31, 1992 after a review of 90 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 - K920997

510(k) Number K920997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date May 31, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGL Device Classification - Class 2, Special Controls

Product Code GGL Control, White-cell
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.