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FDA 510(k)

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-

K-Number: K802886 · 1981-01-28

ApplicantNuclear Diagnostics, Inc.
Decision Date1981-01-28
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K802886. The device is classified under product code JFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-?

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K802886.

When did NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- receive FDA 510(k) clearance?

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- received FDA 510(k) clearance on 1981-01-28, under 510(k) number K802886.

Who is the listed applicant for NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-?

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

What is the FDA product code for NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-?

The FDA product code for NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- is JFH.

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 Diagnostics, 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAY

View all 22 devices →

Related Devices (Code: JFH)

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.

K000257IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6Diagnostic Products Corp.K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEUnited Biotech, Inc.K964756PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KITWano-Tech Corp.K931701IMMULITE PAPDiagnostic Products Corp.K925377IMX PAPAbbott LaboratoriesK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOHybritech, Inc.

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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