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)

NUCLEAR ENTERPRISES 1612 MULTI-WELL

K-Number: K801263 · 1980-06-20

ApplicantNuclear Ent. , Ltd.
Decision Date1980-06-20
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NUCLEAR ENTERPRISES 1612 MULTI-WELL is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Ent. , Ltd.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801263. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLEAR ENTERPRISES 1612 MULTI-WELL?

NUCLEAR ENTERPRISES 1612 MULTI-WELL is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Nuclear Ent. , Ltd.. The 510(k) number is K801263.

When did NUCLEAR ENTERPRISES 1612 MULTI-WELL receive FDA 510(k) clearance?

NUCLEAR ENTERPRISES 1612 MULTI-WELL received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801263.

Who is the listed applicant for NUCLEAR ENTERPRISES 1612 MULTI-WELL?

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

What is the FDA product code for NUCLEAR ENTERPRISES 1612 MULTI-WELL?

The FDA product code for NUCLEAR ENTERPRISES 1612 MULTI-WELL is JJJ.

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

Other records listing Nuclear Ent. , Ltd. 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.

K801264NUCLEAR ENTERPRISES 1600/GAMMA COUNTERK790961LIQUID SCINTILLATION COUNTER

Related Devices (Code: JJJ)

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.

K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.K920559ABBOTT VERTEX ANALYZERAbbott LaboratoriesK900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.K896202MATRIX(TM)-96Canberra Industries, Inc.K894902SOURCEREROakfield Instruments, Ltd.

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.

↑