FDA 510(k)

LPC II

K-Number: K812031 · 1981-08-12

Decision Date1981-08-12

Product CodeGKL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

LPC II is the device name listed in this FDA 510(k) record. The listed applicant is Labtronix Corp.. It received FDA 510(k) clearance on 1981-08-12 under 510(k) number K812031. 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 LPC II?

LPC II is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Labtronix Corp.. The 510(k) number is K812031.

When did LPC II receive FDA 510(k) clearance?

LPC II received FDA 510(k) clearance on 1981-08-12, under 510(k) number K812031.

Who is the listed applicant for LPC II?

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 LPC II?

The FDA product code for LPC II is GKL.

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.

K811084LABTRONIX PLATELET COUNTER(L/O/C.)

Related Devices (Code: GKL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.