FDA 510(k)

COULTER COUNTER MODEL S-PLUS STKR

K-Number: K871837 · 1987-07-02

Decision Date1987-07-02

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

COULTER COUNTER MODEL S-PLUS STKR 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 1987-07-02 under 510(k) number K871837. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER COUNTER MODEL S-PLUS STKR?

COULTER COUNTER MODEL S-PLUS STKR is a medical device that received FDA 510(k) clearance on 1987-07-02. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K871837.

When did COULTER COUNTER MODEL S-PLUS STKR receive FDA 510(k) clearance?

COULTER COUNTER MODEL S-PLUS STKR received FDA 510(k) clearance on 1987-07-02, under 510(k) number K871837.

Who is the listed applicant for COULTER COUNTER MODEL S-PLUS STKR?

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 COUNTER MODEL S-PLUS STKR?

The FDA product code for COULTER COUNTER MODEL S-PLUS STKR is GKZ.

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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.