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FDA 510(k)

COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA

K-Number: K874188 · 1988-01-19

ApplicantCoulter Electronics, Inc.
Decision Date1988-01-19
Product CodeGKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1988-01-19 under 510(k) number K874188. 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 COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA?

COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K874188.

When did COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA receive FDA 510(k) clearance?

COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA received FDA 510(k) clearance on 1988-01-19, under 510(k) number K874188.

Who is the listed applicant for COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA?

The FDA 510(k) record lists Coulter Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA?

The FDA product code for COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA is GKM.

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Other records listing Coulter Electronics, Inc. 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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.

K854685DIGITAL-9 KEY LEUCOCYTE COUNTERFuture Impex Corp.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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