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FDA 510(k)

NEIA PAP ENZYMEIMMUNOASSAY

K-Number: K811757 · 1981-08-13

ApplicantNew England Immunology Assoc.
Decision Date1981-08-13
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEIA PAP ENZYMEIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is New England Immunology Assoc.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K811757. 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 NEIA PAP ENZYMEIMMUNOASSAY?

NEIA PAP ENZYMEIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is New England Immunology Assoc.. The 510(k) number is K811757.

When did NEIA PAP ENZYMEIMMUNOASSAY receive FDA 510(k) clearance?

NEIA PAP ENZYMEIMMUNOASSAY received FDA 510(k) clearance on 1981-08-13, under 510(k) number K811757.

Who is the listed applicant for NEIA PAP ENZYMEIMMUNOASSAY?

The FDA 510(k) record lists New England Immunology Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEIA PAP ENZYMEIMMUNOASSAY?

The FDA product code for NEIA PAP ENZYMEIMMUNOASSAY 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 New England Immunology Assoc. 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.

K813288NEIA TRANSFERRIN ENZYMEIMMUNOASSAYK790490NEIA-FERRITIN ENZYMEIMMUNASSAY KITK780490NEIA-FERRITIN ENZYMEIMMUNOASSAY

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

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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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