Cleared Traditional

K875216 - HIGH PERFORMANCE CALIBRATORS

K875216 is an FDA 510(k) clearance for HIGH PERFORMANCE CALIBRATORS, manufactured by Rapid Diagnostic Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DKB cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K875216 · Rapid Diagnostic Laboratories, Inc. · Toxicology device
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Jun 1988
Decision
183d
Days
Class 2
Risk

K875216 is an FDA 510(k) clearance for the HIGH PERFORMANCE CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Rapid Diagnostic Laboratories, Inc. (Port Washington, US). The FDA issued a Cleared decision on June 22, 1988 after a review of 183 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rapid Diagnostic Laboratories, Inc. devices

FDA 510(k) Submission Details - K875216

510(k) Number K875216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date June 22, 1988
Days to Decision 183 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 87d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKB Device Classification - Class 2, Special Controls

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKB Calibrators, Drug Mixture

All 88
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K875216.
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