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FDA 510(k)

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG

K-Number: K890416 · 1989-02-22

ApplicantAtlantic Antibodies
Decision Date1989-02-22
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1989-02-22 under 510(k) number K890416. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ(TM) ANTIBODY REAGENT SET II FOR IGG?

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG is a medical device that received FDA 510(k) clearance on 1989-02-22. The listed applicant is Atlantic Antibodies. The 510(k) number is K890416.

When did SPQ(TM) ANTIBODY REAGENT SET II FOR IGG receive FDA 510(k) clearance?

SPQ(TM) ANTIBODY REAGENT SET II FOR IGG received FDA 510(k) clearance on 1989-02-22, under 510(k) number K890416.

Who is the listed applicant for SPQ(TM) ANTIBODY REAGENT SET II FOR IGG?

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 SPQ(TM) ANTIBODY REAGENT SET II FOR IGG?

The FDA product code for SPQ(TM) ANTIBODY REAGENT SET II FOR IGG is DEW.

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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 IGMK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPTK890417SPQ(TM) ANTIBODY REAGENT SET II FOR C3

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott 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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