Cleared Traditional

K852107 - SICKLE-CHEX (FDA 510(k) Clearance)

K852107 · Streck Laboratories, Inc. · Hematology device
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Jul 1985
Decision
51d
Days
-
Risk

K852107 is an FDA 510(k) clearance for the SICKLE-CHEX.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel. 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

Submission Details

510(k) Number K852107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date July 05, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -