Cleared Traditional

K803051 - FLAME PHOTOMETRY REAGENTS

K803051 is the FDA 510(k) clearance for FLAME PHOTOMETRY REAGENTS by Laboratory Products, Inc.. It is a Class 2 Pathology device (product code JIX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K803051 · Laboratory Products, Inc. · Pathology device
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Jan 1981
Decision
38d
Days
Class 2
Risk

K803051 is an FDA 510(k) clearance for the FLAME PHOTOMETRY REAGENTS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.1150 - the FDA pathology 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 Laboratory Products, Inc. devices

Submission Details

510(k) Number K803051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1980
Decision Date January 09, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 77d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Pathology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 228
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K803051.
BECKMAN ICS CALIBRATOR
K812649 · Beckman Instruments, Inc. · Oct 1981
HITACHI 705 CALIBRATOR
K811921 · Boehringer Mannheim Corp. · Jul 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · Boehringer Mannheim Corp. · Apr 1981
ALBUMIN/TOTAL PROTEIN STANDARDS
K802632 · Gilford Diagnostics · Dec 1980
BUN/GLUCOSE STANDARDS
K802633 · Gilford Diagnostics · Dec 1980
COMBUNED CALCIUM AND PHOSPHORUS STD.
K802824 · Mallinckrodt Critical Care · Dec 1980