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FDA 510(k)

BIOMEK 1000C AUTOMATED LABORATORY WORK STATION

K-Number: K871838 · 1987-05-26

ApplicantBeckman Instruments, Inc.
Decision Date1987-05-26
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOMEK 1000C AUTOMATED LABORATORY WORK STATION 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 1987-05-26 under 510(k) number K871838. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMEK 1000C AUTOMATED LABORATORY WORK STATION?

BIOMEK 1000C AUTOMATED LABORATORY WORK STATION is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K871838.

When did BIOMEK 1000C AUTOMATED LABORATORY WORK STATION receive FDA 510(k) clearance?

BIOMEK 1000C AUTOMATED LABORATORY WORK STATION received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871838.

Who is the listed applicant for BIOMEK 1000C AUTOMATED LABORATORY WORK STATION?

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 BIOMEK 1000C AUTOMATED LABORATORY WORK STATION?

The FDA product code for BIOMEK 1000C AUTOMATED LABORATORY WORK STATION is JJG.

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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: JJG)

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, 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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