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FDA 510(k)

LABTRONIX PLATELET COUNTER(L/O/C.)

K-Number: K811084 · 1981-07-23

ApplicantLabtronix Corp.
Decision Date1981-07-23
Product CodeGLG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LABTRONIX PLATELET COUNTER(L/O/C.) is the device name listed in this FDA 510(k) record. The listed applicant is Labtronix Corp.. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K811084. The device is classified under product code GLG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABTRONIX PLATELET COUNTER(L/O/C.)?

LABTRONIX PLATELET COUNTER(L/O/C.) is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Labtronix Corp.. The 510(k) number is K811084.

When did LABTRONIX PLATELET COUNTER(L/O/C.) receive FDA 510(k) clearance?

LABTRONIX PLATELET COUNTER(L/O/C.) received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811084.

Who is the listed applicant for LABTRONIX PLATELET COUNTER(L/O/C.)?

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

What is the FDA product code for LABTRONIX PLATELET COUNTER(L/O/C.)?

The FDA product code for LABTRONIX PLATELET COUNTER(L/O/C.) is GLG.

Related Clinical Trials

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.

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Other records listing Labtronix Corp. 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.

K812031LPC II

Related Devices (Code: GLG)

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.

K842921REES & ECKER DILUTION FLUIDE K Ind., Inc.K772105PLATELET KITStreck Laboratories, 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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