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FDA 510(k)

PET-DOSE

K-Number: K042746 · 2004-11-22

ApplicantComecer S.R.L.
Decision Date2004-11-22
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PET-DOSE is the device name listed in this FDA 510(k) record. The listed applicant is Comecer S.R.L.. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K042746. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PET-DOSE?

PET-DOSE is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Comecer S.R.L.. The 510(k) number is K042746.

When did PET-DOSE receive FDA 510(k) clearance?

PET-DOSE received FDA 510(k) clearance on 2004-11-22, under 510(k) number K042746.

Who is the listed applicant for PET-DOSE?

The FDA 510(k) record lists Comecer S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PET-DOSE?

The FDA product code for PET-DOSE is KPT. This falls under the In Vitro Diagnostics category.

Related Devices (Code: KPT)

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.

K192199CRC PC Smart Chamber K1Capintec, Inc.K162394CRC-77tHRCapintec, Inc.K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.K030066CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165Nuclear Associates

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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