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FDA 510(k)

ARRAY(R) 360

K-Number: K922273 · 1992-08-19

ApplicantBeckman Instruments, Inc.
Decision Date1992-08-19
Product CodeJQX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARRAY(R) 360 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1992-08-19 under 510(k) number K922273. The device is classified under product code JQX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARRAY(R) 360?

ARRAY(R) 360 is a medical device that received FDA 510(k) clearance on 1992-08-19. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K922273.

When did ARRAY(R) 360 receive FDA 510(k) clearance?

ARRAY(R) 360 received FDA 510(k) clearance on 1992-08-19, under 510(k) number K922273.

Who is the listed applicant for ARRAY(R) 360?

The FDA 510(k) record lists Beckman Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARRAY(R) 360?

The FDA product code for ARRAY(R) 360 is JQX.

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Other records listing Beckman Instruments, Inc. 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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Related Devices (Code: JQX)

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.

K962294IMMAGE IMMUNOCHEMISTRY SYSTEMBeckman Instruments, Inc.K885263QMS(TM) - THEOPHYLLINESeradyn, Inc.K851253TDX ANALYZER W/NEPHELOMETRY CAROUSELAbbott LaboratoriesK851234A-JUST TURBIDITY METERAbbott LaboratoriesK801362ALBUMIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.K801089J.T. BAKER NEPHELOMETERJ.T. Baker Chemical Co.

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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