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FDA 510(k)

PCR ELEVA 1.2

K-Number: K093355 · 2010-01-08

ApplicantPhilips Medical Systems, Inc.
Decision Date2010-01-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PCR ELEVA 1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 2010-01-08 under 510(k) number K093355. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCR ELEVA 1.2?

PCR ELEVA 1.2 is a medical device that received FDA 510(k) clearance on 2010-01-08. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K093355.

When did PCR ELEVA 1.2 receive FDA 510(k) clearance?

PCR ELEVA 1.2 received FDA 510(k) clearance on 2010-01-08, under 510(k) number K093355.

Who is the listed applicant for PCR ELEVA 1.2?

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

What is the FDA product code for PCR ELEVA 1.2?

The FDA product code for PCR ELEVA 1.2 is LLZ.

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Other records listing Philips Medical Systems, Inc. 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.

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Related Devices (Code: LLZ)

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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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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