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FDA 510(k)

MICROALBUMINURIA ASSAY

K-Number: K862671 · 1986-09-18

ApplicantOrion Corp.
Decision Date1986-09-18
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MICROALBUMINURIA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-09-18 under 510(k) number K862671. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROALBUMINURIA ASSAY?

MICROALBUMINURIA ASSAY is a medical device that received FDA 510(k) clearance on 1986-09-18. The listed applicant is Orion Corp.. The 510(k) number is K862671.

When did MICROALBUMINURIA ASSAY receive FDA 510(k) clearance?

MICROALBUMINURIA ASSAY received FDA 510(k) clearance on 1986-09-18, under 510(k) number K862671.

Who is the listed applicant for MICROALBUMINURIA ASSAY?

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

What is the FDA product code for MICROALBUMINURIA ASSAY?

The FDA product code for MICROALBUMINURIA ASSAY is DCF.

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Other records listing Orion Corp. 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

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Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.

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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