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FDA 510(k)

RADCAL MODEL 4046 RADIONUCLIDE CALIBR

K-Number: K841785 · 1984-07-16

ApplicantRadcal Corp.
Decision Date1984-07-16
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADCAL MODEL 4046 RADIONUCLIDE CALIBR is the device name listed in this FDA 510(k) record. The listed applicant is Radcal Corp.. It received FDA 510(k) clearance on 1984-07-16 under 510(k) number K841785. 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 RADCAL MODEL 4046 RADIONUCLIDE CALIBR?

RADCAL MODEL 4046 RADIONUCLIDE CALIBR is a medical device that received FDA 510(k) clearance on 1984-07-16. The listed applicant is Radcal Corp.. The 510(k) number is K841785.

When did RADCAL MODEL 4046 RADIONUCLIDE CALIBR receive FDA 510(k) clearance?

RADCAL MODEL 4046 RADIONUCLIDE CALIBR received FDA 510(k) clearance on 1984-07-16, under 510(k) number K841785.

Who is the listed applicant for RADCAL MODEL 4046 RADIONUCLIDE CALIBR?

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

What is the FDA product code for RADCAL MODEL 4046 RADIONUCLIDE CALIBR?

The FDA product code for RADCAL MODEL 4046 RADIONUCLIDE CALIBR 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 Radcal 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.

K841787RADCAL MODEL 4050 RADIONUCLIDE CALIBK841786RADCAL MODEL 4051 RADIONUCLIDE CALIBRAK828249MODEL 4045 RADIONUCLIDE CALIBRATOR

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.K042746PET-DOSEComecer S.R.L.

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.

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