Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAL-3 CALIBRATED RADIOACTIVITY ASSAYER

K-Number: K811320 · 1981-06-02

ApplicantDosimeter Corp.
Decision Date1981-06-02
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAL-3 CALIBRATED RADIOACTIVITY ASSAYER is the device name listed in this FDA 510(k) record. The listed applicant is Dosimeter Corp.. It received FDA 510(k) clearance on 1981-06-02 under 510(k) number K811320. 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 CAL-3 CALIBRATED RADIOACTIVITY ASSAYER?

CAL-3 CALIBRATED RADIOACTIVITY ASSAYER is a medical device that received FDA 510(k) clearance on 1981-06-02. The listed applicant is Dosimeter Corp.. The 510(k) number is K811320.

When did CAL-3 CALIBRATED RADIOACTIVITY ASSAYER receive FDA 510(k) clearance?

CAL-3 CALIBRATED RADIOACTIVITY ASSAYER received FDA 510(k) clearance on 1981-06-02, under 510(k) number K811320.

Who is the listed applicant for CAL-3 CALIBRATED RADIOACTIVITY ASSAYER?

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

What is the FDA product code for CAL-3 CALIBRATED RADIOACTIVITY ASSAYER?

The FDA product code for CAL-3 CALIBRATED RADIOACTIVITY ASSAYER 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑