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FDA 510(k)

BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT

K-Number: K934293 · 1994-07-06

ApplicantBeckman-Diagnostic Systems Group
Decision Date1994-07-06
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN PANCREATIC AMYLASE (PAMY) 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 1994-07-06 under 510(k) number K934293. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT?

BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K934293.

When did BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT receive FDA 510(k) clearance?

BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT received FDA 510(k) clearance on 1994-07-06, under 510(k) number K934293.

Who is the listed applicant for BECKMAN PANCREATIC AMYLASE (PAMY) 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 PANCREATIC AMYLASE (PAMY) REAGENT?

The FDA product code for BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT is JFJ.

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 DELTAK934068BECKMAN DIRECT BILIRUBIN REAGENT

View all 11 devices →

Related Devices (Code: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, 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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