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FDA 510(k)

SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER

K-Number: K882612 · 1988-09-07

ApplicantBaker Instructions Corp.
Decision Date1988-09-07
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1988-09-07 under 510(k) number K882612. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER?

SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is Baker Instructions Corp.. The 510(k) number is K882612.

When did SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER receive FDA 510(k) clearance?

SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER received FDA 510(k) clearance on 1988-09-07, under 510(k) number K882612.

Who is the listed applicant for SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER?

The FDA 510(k) record lists Baker Instructions Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER?

The FDA product code for SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER is GKZ.

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Other records listing Baker Instructions Corp. 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.

K873596BAKER TDM THEOPHYLLINE ASSAYK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK850386SYSTEM 8000 CELL COUNTERK833116SPIRIT CHEMISTRY SYSTEMK832716ENCORE CHEMISTRY ANALYZER

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Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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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