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FDA 510(k)

SPQ TEST SYSTEM FOR TRANSFERRIN

K-Number: K850589 · 1985-03-05

ApplicantApplications Lab
Decision Date1985-03-05
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ TEST SYSTEM FOR TRANSFERRIN is the device name listed in this FDA 510(k) record. The listed applicant is Applications Lab. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K850589. 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 TEST SYSTEM FOR TRANSFERRIN?

SPQ TEST SYSTEM FOR TRANSFERRIN is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Applications Lab. The 510(k) number is K850589.

When did SPQ TEST SYSTEM FOR TRANSFERRIN receive FDA 510(k) clearance?

SPQ TEST SYSTEM FOR TRANSFERRIN received FDA 510(k) clearance on 1985-03-05, under 510(k) number K850589.

Who is the listed applicant for SPQ TEST SYSTEM FOR TRANSFERRIN?

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

What is the FDA product code for SPQ TEST SYSTEM FOR TRANSFERRIN?

The FDA product code for SPQ TEST SYSTEM FOR TRANSFERRIN is DDG.

Related Clinical Trials

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.

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Other records listing Applications Lab 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.

K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MK850587SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSINK850584SPQ TEST SYSTEM FOR HAPTOGLOBINK850603SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULINK850588SPQ TEST SYSTEM FOR COMPLEMENT C3K850590SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

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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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