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FDA 510(k)

MANUAL BLOOD CELL COUNTING DEVICE

K-Number: K841026 · 1984-04-04

ApplicantInstrumentation Laboratory CO
Decision Date1984-04-04
Product CodeGKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MANUAL BLOOD CELL COUNTING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K841026. 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 MANUAL BLOOD CELL COUNTING DEVICE?

MANUAL BLOOD CELL COUNTING DEVICE is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K841026.

When did MANUAL BLOOD CELL COUNTING DEVICE receive FDA 510(k) clearance?

MANUAL BLOOD CELL COUNTING DEVICE received FDA 510(k) clearance on 1984-04-04, under 510(k) number K841026.

Who is the listed applicant for MANUAL BLOOD CELL COUNTING DEVICE?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL BLOOD CELL COUNTING DEVICE?

The FDA product code for MANUAL BLOOD CELL COUNTING DEVICE is GKM.

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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.K854685DIGITAL-9 KEY LEUCOCYTE COUNTERFuture Impex Corp.K771580TEKTALLY 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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