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FDA 510(k)

DIGITAL-9 KEY LEUCOCYTE COUNTER

K-Number: K854685 · 1986-04-04

ApplicantFuture Impex Corp.
Decision Date1986-04-04
Product CodeGKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIGITAL-9 KEY LEUCOCYTE COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Future Impex Corp.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K854685. The device is classified under product code GKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL-9 KEY LEUCOCYTE COUNTER?

DIGITAL-9 KEY LEUCOCYTE COUNTER is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Future Impex Corp.. The 510(k) number is K854685.

When did DIGITAL-9 KEY LEUCOCYTE COUNTER receive FDA 510(k) clearance?

DIGITAL-9 KEY LEUCOCYTE COUNTER received FDA 510(k) clearance on 1986-04-04, under 510(k) number K854685.

Who is the listed applicant for DIGITAL-9 KEY LEUCOCYTE COUNTER?

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

What is the FDA product code for DIGITAL-9 KEY LEUCOCYTE COUNTER?

The FDA product code for DIGITAL-9 KEY LEUCOCYTE COUNTER is GKM.

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Other records listing Future Impex 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.

K861487ST-90 SPIRO ANALIZERK854686TE-25 COAGURO METERK854687ERMA HB-METER MODEL 303NK854677ERMA PC-604 BLOOD CELL COUNTERK854678ERMA PC-602 PC-603 BLOOD CELL COUNTERK854679PHOTIC-100 SPECTROPHOTOMETER

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Related Devices (Code: GKM)

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.

K874188COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STACoulter Electronics, Inc.K841026MANUAL BLOOD CELL COUNTING DEVICEInstrumentation Laboratory COK771580TEKTALLY IIScientific Products

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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