Cleared Traditional

K800852 - HEMESPEC CHECK SET

K800852 is an FDA 510(k) clearance for HEMESPEC CHECK SET, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code KRZ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K800852 · Helena Laboratories · Hematology device
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May 1980
Decision
17d
Days
Class 2
Risk

K800852 is an FDA 510(k) clearance for the HEMESPEC CHECK SET. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 17 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 Helena Laboratories devices

FDA 510(k) Submission Details - K800852

510(k) Number K800852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1980
Decision Date May 02, 1980
Days to Decision 17 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
96d faster than avg
Panel avg: 113d · This submission: 17d
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 K800852.
CAL-CHEX, A HEMATOLOGY CALIBRATOR
K840261 · Streck Laboratories, Inc. · Feb 1984
CALIBRATOR 282
K831872 · Bionostics, Inc. · Jul 1983
SERALYZER HEMOGLOBIN CALIBRATORS
K822046 · Miles Laboratories, Inc. · Jul 1982
SANDARE CYANMETHEMOGLOBIN STANDARD
K792358 · Sandare Chemical Co., Inc. · Dec 1979