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FDA 510(k)

CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS

K-Number: K071396 · 2007-06-28

ApplicantCapintec, Inc.
Decision Date2007-06-28
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2007-06-28 under 510(k) number K071396. 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 CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS?

CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS is a medical device that received FDA 510(k) clearance on 2007-06-28. The listed applicant is Capintec, Inc.. The 510(k) number is K071396.

When did CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS receive FDA 510(k) clearance?

CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS received FDA 510(k) clearance on 2007-06-28, under 510(k) number K071396.

Who is the listed applicant for CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS?

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

What is the FDA product code for CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS?

The FDA product code for CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS is KPT. This falls under the In Vitro Diagnostics category.

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 Capintec, 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.

K192199CRC PC Smart Chamber K1K162394CRC-77tHRK101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWK052595CRC 15ULTRAK0301752 BASICK020150CRC-15BT

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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.K042746PET-DOSEComecer S.R.L.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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