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FDA 510(k)

RADIONUCLIDE DOSE CALIBRATOR

K-Number: K813379 · 1982-01-22

ApplicantMedi Nuclear Corp., Inc.
Decision Date1982-01-22
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIONUCLIDE DOSE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medi Nuclear Corp., Inc.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813379. 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 RADIONUCLIDE DOSE CALIBRATOR?

RADIONUCLIDE DOSE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K813379.

When did RADIONUCLIDE DOSE CALIBRATOR receive FDA 510(k) clearance?

RADIONUCLIDE DOSE CALIBRATOR received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813379.

Who is the listed applicant for RADIONUCLIDE DOSE CALIBRATOR?

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

What is the FDA product code for RADIONUCLIDE DOSE CALIBRATOR?

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

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Other records listing Medi Nuclear Corp., 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.

K082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEMK080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510K080657NEB-90 LARGE VOLUME MEDICATION NEBULIZERK915075NEBULIZER (DIRECT PATIENT INTERFACE)K865107AERO-VENT AEROSOL UNITK865093SAFE-T-SHIELD MOUTHPIECE

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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.K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.K042746PET-DOSEComecer S.R.L.

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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