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FDA 510(k)

NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM

K-Number: K860138 · 1986-03-28

ApplicantSigma Diagnostics, Inc.
Decision Date1986-03-28
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-28 under 510(k) number K860138. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM?

NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM is a medical device that received FDA 510(k) clearance on 1986-03-28. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K860138.

When did NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM receive FDA 510(k) clearance?

NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM received FDA 510(k) clearance on 1986-03-28, under 510(k) number K860138.

Who is the listed applicant for NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM?

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

What is the FDA product code for NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM?

The FDA product code for NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM is DDB.

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Other records listing Sigma Diagnostics, Inc. 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: DDB)

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.

K161508CeruloplasminBeckman Coulter Ireland, Inc.K122965HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.K053074N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, 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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