Glocyte Automated Cell Counter System
K-Number: K152776 · 2016-05-27
ApplicantAdvanced Instruments, Inc.
Decision Date2016-05-27
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Glocyte Automated Cell Counter System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instruments, Inc.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K152776. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Glocyte Automated Cell Counter System?
Glocyte Automated Cell Counter System is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is Advanced Instruments, Inc.. The 510(k) number is K152776.
When did Glocyte Automated Cell Counter System receive FDA 510(k) clearance?
Glocyte Automated Cell Counter System received FDA 510(k) clearance on 2016-05-27, under 510(k) number K152776.
Who is the listed applicant for Glocyte Automated Cell Counter System?
The FDA 510(k) record lists Advanced Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Glocyte Automated Cell Counter System?
The FDA product code for Glocyte Automated Cell Counter System is GKL.
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.