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FDA 510(k)

IMMUNOMEDICS SERUM ELISA TEST SYSTEM

K-Number: K861362 · 1986-06-06

ApplicantImmunomedics, Inc.
Decision Date1986-06-06
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOMEDICS SERUM ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunomedics, Inc.. It received FDA 510(k) clearance on 1986-06-06 under 510(k) number K861362. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOMEDICS SERUM ELISA TEST SYSTEM?

IMMUNOMEDICS SERUM ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-06. The listed applicant is Immunomedics, Inc.. The 510(k) number is K861362.

When did IMMUNOMEDICS SERUM ELISA TEST SYSTEM receive FDA 510(k) clearance?

IMMUNOMEDICS SERUM ELISA TEST SYSTEM received FDA 510(k) clearance on 1986-06-06, under 510(k) number K861362.

Who is the listed applicant for IMMUNOMEDICS SERUM ELISA TEST SYSTEM?

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

What is the FDA product code for IMMUNOMEDICS SERUM ELISA TEST SYSTEM?

The FDA product code for IMMUNOMEDICS SERUM ELISA TEST SYSTEM is CZW.

Related Clinical Trials

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Other records listing Immunomedics, 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.

K972873IMMUSTRIP HAMA IGGK873741IMMUSTRIP(TM) SM ELISA TEST SYSTEMK870903IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM

Related Devices (Code: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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