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FDA 510(k)

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM

K-Number: K860851 · 1986-03-28

ApplicantNichols Institute Diagnostics
Decision Date1986-03-28
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1986-03-28 under 510(k) number K860851. The device is classified under product code DGO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM?

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-28. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K860851.

When did ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1986-03-28, under 510(k) number K860851.

Who is the listed applicant for ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM?

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

What is the FDA product code for ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM?

The FDA product code for ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM is DGO.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

View all 68 devices →

Related Devices (Code: DGO)

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.

K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.K920087IGE EIA TEST KITThe Binding Site, Ltd.K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.K893125BECKMAN EPSILON(TM) IGE REAGENT KITBeckman Instruments, Inc.K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5Diagnostic Products Corp.

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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