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FDA 510(k)

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST

K-Number: K861167 · 1986-04-25

ApplicantAtlantic Antibodies
Decision Date1986-04-25
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1986-04-25 under 510(k) number K861167. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST?

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST is a medical device that received FDA 510(k) clearance on 1986-04-25. The listed applicant is Atlantic Antibodies. The 510(k) number is K861167.

When did IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST receive FDA 510(k) clearance?

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST received FDA 510(k) clearance on 1986-04-25, under 510(k) number K861167.

Who is the listed applicant for IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST?

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

What is the FDA product code for IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST?

The FDA product code for IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST is CZP.

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Other records listing Atlantic Antibodies 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.

K892526SPQ TM TEST SYSTEM II FOR CRPK891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BK890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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