Manual Blood Cell Counting Device

FDA 510(k) K841026 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK841026

Submission

Device name
Manual Blood Cell Counting Device
Applicant
Instrumentation Laboratory CO
Mchenry, IL, US
Received
March 12, 1984
Decision date
April 4, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKM – Hand-Tally, Differential
Device class
Class I (low risk)
Regulation
21 CFR 864.6160
Specialty
Hematology

Other 510(k)s with product code GKM

510(k)DeviceApplicantDecision
K874188Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK StaGKM · Traditional Coulter Electronics, Inc.01/19/1988SE
K854685DIGITAL-9 Key Leucocyte CounterGKM · Traditional Future Impex Corp.04/04/1986SE
K771580Tektally IIGKM · Traditional Scientific Products09/02/1977SE

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Questions and answers

When was Manual Blood Cell Counting Device cleared by the FDA?

Manual Blood Cell Counting Device (K841026) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 23 days after the submission was received.

What is the product code of K841026?

The FDA product code is GKM – Hand-Tally, Differential, a Class I (low risk) device regulated under 21 CFR 864.6160.