Cleared Traditional

K934271 - BECKMAN SYNCHRON LACTATE REAGENT

K934271 is an FDA 510(k) clearance for BECKMAN SYNCHRON LACTATE REAGENT, manufactured by Beckman-Diagnostic Systems Group. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K934271 · Beckman-Diagnostic Systems Group · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
70d
Days
Class 1
Risk

K934271 is an FDA 510(k) clearance for the BECKMAN SYNCHRON LACTATE REAGENT. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on November 9, 1993 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - 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: 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 Beckman-Diagnostic Systems Group devices

FDA 510(k) Submission Details - K934271

510(k) Number K934271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date November 09, 1993
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

KHP Device Classification - Class 1, General Controls

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
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 - KHP Acid, Lactic, Enzymatic Method

All 20
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K934271.
LACTEST I
K971944 · Jwt, Inc. · Dec 1997
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · Boehringer Mannheim Corp. · Aug 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · Nova Biomedical Corp. · Mar 1995
DIMENSION(R) LACTIC ACID METHOD
K914508 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991
KODAK EKTACHEM DT SLIDES (LAC)
K913197 · Eastman Kodak Company · Aug 1991
SYNCHRON LACTATE REAGENT
K910534 · Beckman Instruments, Inc. · Apr 1991