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FDA 510(k)

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF

K-Number: K890563 · 1989-03-03

ApplicantAtlantic Antibodies
Decision Date1989-03-03
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1989-03-03 under 510(k) number K890563. The device is classified under product code DDG. 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 TRF?

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF is a medical device that received FDA 510(k) clearance on 1989-03-03. The listed applicant is Atlantic Antibodies. The 510(k) number is K890563.

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

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF received FDA 510(k) clearance on 1989-03-03, under 510(k) number K890563.

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

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 TRF?

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

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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 BK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPTK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890417SPQ(TM) ANTIBODY REAGENT SET II FOR C3

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Related Devices (Code: DDG)

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.

K240987Access sTfRBeckman Coulter, Inc.K190495TransferrinBiosystems S.A.K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo)K120236TRANSFERRIN KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K080634ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495Beckman Coulter, Inc.K081299DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTASiemens Healthcare Diagnostics, Inc.

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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