Cleared Traditional

K822046 - SERALYZER HEMOGLOBIN CALIBRATORS

K822046 is an FDA 510(k) clearance for SERALYZER HEMOGLOBIN CALIBRATORS, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Hematology device with product code KRZ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K822046 · Miles Laboratories, Inc. · Hematology device
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Jul 1982
Decision
18d
Days
Class 2
Risk

K822046 is an FDA 510(k) clearance for the SERALYZER HEMOGLOBIN CALIBRATORS. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8165 - 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 Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K822046

510(k) Number K822046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1982
Decision Date July 30, 1982
Days to Decision 18 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
95d faster than avg
Panel avg: 113d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRZ Device Classification - Class 2, Special Controls

Product Code KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8165
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 - KRZ Calibrator For Hemoglobin And Hematocrit Measurement

All 17
Devices cleared under the same product code (KRZ) and FDA review panel - the closest regulatory comparables to K822046.
DADE HEMATOLOGY CALIBRATOR PLUS
K840010 · American Dade · Apr 1984
CAL-CHEX, A HEMATOLOGY CALIBRATOR
K840261 · Streck Laboratories, Inc. · Feb 1984
CALIBRATOR 282
K831872 · Bionostics, Inc. · Jul 1983
HEMESPEC CHECK SET
K800852 · Helena Laboratories · May 1980
SANDARE CYANMETHEMOGLOBIN STANDARD
K792358 · Sandare Chemical Co., Inc. · Dec 1979