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FDA 510(k)

BECKMAN SYNCHRON LACTATE REAGENT

K-Number: K934271 · 1993-11-09

ApplicantBeckman-Diagnostic Systems Group
Decision Date1993-11-09
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN SYNCHRON LACTATE REAGENT 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 1993-11-09 under 510(k) number K934271. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN SYNCHRON LACTATE REAGENT?

BECKMAN SYNCHRON LACTATE REAGENT is a medical device that received FDA 510(k) clearance on 1993-11-09. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K934271.

When did BECKMAN SYNCHRON LACTATE REAGENT receive FDA 510(k) clearance?

BECKMAN SYNCHRON LACTATE REAGENT received FDA 510(k) clearance on 1993-11-09, under 510(k) number K934271.

Who is the listed applicant for BECKMAN SYNCHRON LACTATE REAGENT?

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 SYNCHRON LACTATE REAGENT?

The FDA product code for BECKMAN SYNCHRON LACTATE REAGENT is KHP.

Related Clinical Trials

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.

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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: KHP)

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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, Inc.

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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