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FDA 510(k)

I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS

K-Number: K945522 · 1994-12-12

ApplicantBeckman-Diagnostic Systems Group
Decision Date1994-12-12
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS 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 1994-12-12 under 510(k) number K945522. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS?

I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K945522.

When did I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS receive FDA 510(k) clearance?

I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS received FDA 510(k) clearance on 1994-12-12, under 510(k) number K945522.

Who is the listed applicant for I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS?

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 I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS?

The FDA product code for I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS is DFT.

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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.

K944604CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMSK944605CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMK944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSK942676SYNCHRON CX3 DELTAK934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENTK934068BECKMAN DIRECT BILIRUBIN REAGENT

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Related Devices (Code: DFT)

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.

K983132IGMAbbott LaboratoriesK962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, Inc.K884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOrion Diagnostica, 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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