Cleared Traditional

K931887 - BICARBONATE

K931887 is an FDA 510(k) clearance for BICARBONATE, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K931887 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1993
Decision
110d
Days
Class 2
Risk

K931887 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 August 3, 1993 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K931887

510(k) Number K931887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1993
Decision Date August 03, 1993
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHS Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - KHS Enzymatic, Carbon-dioxide

All 82
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K931887.
CARBON DIOXIDE (C02)
K942735 · Teco Diagnostics · Mar 1995
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994
ENZYMATIC CO2 REAGENT, MODIFICATION
K932267 · Intersect Systems, Inc. · Sep 1993
SYNERMED ENZYMATIC CO2 REAGENT KIT
K924428 · Synermed, Inc. · Dec 1992
BICARBONATE
K924711 · Em Diagnostic Systems, Inc. · Dec 1992
COULTER CARBON DIOXIDE REAGENT
K914486 · Coulter Corp. · Nov 1991