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FDA 510(k)

PLA-MATE

K-Number: K803071 · 1981-07-24

ApplicantLabex, Inc.
Decision Date1981-07-24
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLA-MATE is the device name listed in this FDA 510(k) record. The listed applicant is Labex, Inc.. It received FDA 510(k) clearance on 1981-07-24 under 510(k) number K803071. 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 PLA-MATE?

PLA-MATE is a medical device that received FDA 510(k) clearance on 1981-07-24. The listed applicant is Labex, Inc.. The 510(k) number is K803071.

When did PLA-MATE receive FDA 510(k) clearance?

PLA-MATE received FDA 510(k) clearance on 1981-07-24, under 510(k) number K803071.

Who is the listed applicant for PLA-MATE?

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

What is the FDA product code for PLA-MATE?

The FDA product code for PLA-MATE is GKL.

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.

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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