Cleared Traditional

K924711 - BICARBONATE

K924711 is the FDA 510(k) clearance for BICARBONATE by Em Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code KHS) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K924711 · Em Diagnostic Systems, Inc. · Hematology device
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Dec 1992
Decision
76d
Days
Class 2
Risk

K924711 is an FDA 510(k) clearance for the BICARBONATE. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1160 - 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K924711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date December 03, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 113d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K924711.
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994
BICARBONATE
K931887 · Em Diagnostic Systems, Inc. · Aug 1993
SYNERMED ENZYMATIC CO2 REAGENT KIT
K924428 · Synermed, Inc. · Dec 1992
COULTER CARBON DIOXIDE REAGENT
K914486 · Coulter Corp. · Nov 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806 · Em Diagnostic Systems, Inc. · Sep 1991
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
K903409 · Em Diagnostic Systems, Inc. · Oct 1990