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FDA 510(k)

BECKMAN CX AMMONIA/ALCOHOL CONTROL

K-Number: K934467 · 1993-10-27

ApplicantBeckman-Diagnostic Systems Group
Decision Date1993-10-27
Product CodeDKC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BECKMAN CX AMMONIA/ALCOHOL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Beckman-Diagnostic Systems Group. It received FDA 510(k) clearance on 1993-10-27 under 510(k) number K934467. The device is classified under product code DKC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN CX AMMONIA/ALCOHOL CONTROL?

BECKMAN CX AMMONIA/ALCOHOL CONTROL is a medical device that received FDA 510(k) clearance on 1993-10-27. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K934467.

When did BECKMAN CX AMMONIA/ALCOHOL CONTROL receive FDA 510(k) clearance?

BECKMAN CX AMMONIA/ALCOHOL CONTROL received FDA 510(k) clearance on 1993-10-27, under 510(k) number K934467.

Who is the listed applicant for BECKMAN CX AMMONIA/ALCOHOL CONTROL?

The FDA 510(k) record lists Beckman-Diagnostic Systems Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BECKMAN CX AMMONIA/ALCOHOL CONTROL?

The FDA product code for BECKMAN CX AMMONIA/ALCOHOL CONTROL is DKC.

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Other records listing Beckman-Diagnostic Systems Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSK944604CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMSK944605CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMK944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSK942676SYNCHRON CX3 DELTAK934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT

View all 11 devices →

Related Devices (Code: DKC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031392MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROLMedical Analysis Systems, Inc.K935819QUALITY CONTROL MATERIAL (ASSAYED)Columbia Diagnostics, Inc.K933425AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812Sigma Diagnostics, Inc.K932067ETHANOL CONTROLS, URINE, LEVELS 1,II, AND IIISigma Diagnostics, Inc.K912827SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3Cala DiagnosticsK912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2Cala Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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