Cleared Traditional

K834099 - BLOOD GLUCOSE MONITOR

K834099 is an FDA 510(k) clearance for BLOOD GLUCOSE MONITOR, manufactured by Healthdyne, Inc.. The device is a Class 1 Hematology device with product code JJQ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834099 · Healthdyne, Inc. · Hematology device
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Feb 1984
Decision
67d
Days
Class 1
Risk

K834099 is an FDA 510(k) clearance for the BLOOD GLUCOSE MONITOR. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2300 - 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K834099

510(k) Number K834099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date February 03, 1984
Days to Decision 67 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
46d faster than avg
Panel avg: 113d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 160
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K834099.
ORTHO MICROWELL READER
K841557 · Ortho Diagnostic Systems, Inc. · May 1984
LABSYSTEMS UNISKAN
K841214 · Labsystems, Inc. · Apr 1984
ULTROSPEC W/APPLE II -4050-
K834489 · Lkb Instruments, Inc. · Feb 1984
HYBRITECH 405-500 NM FILTER MODULE
K832397 · Hybritech, Inc. · Aug 1983
PHOTON IMMUNOASSAY ANALYZER
K832364 · Hybritech, Inc. · Aug 1983
SPECTROPHOTOMETER #390
K832206 · Abbott Diagnostics · Aug 1983