Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta

FDA 510(k) K874188 · Coulter Electronics, Inc.

Substantially Equivalent

510(k) numberK874188

Submission

Device name
Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta
Applicant
Coulter Electronics, Inc.
Hialeah, FL, US
Received
October 14, 1987
Decision date
January 19, 1988
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
K854685DIGITAL-9 Key Leucocyte CounterGKM · Traditional Future Impex Corp.04/04/1986SE
K841026Manual Blood Cell Counting DeviceGKM · Traditional Instrumentation Laboratory CO04/04/1984SE
K771580Tektally IIGKM · Traditional Scientific Products09/02/1977SE

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Questions and answers

When was Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta cleared by the FDA?

Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta (K874188) received a 510(k) decision of Substantially Equivalent on January 19, 1988, 97 days after the submission was received.

What is the product code of K874188?

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