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FDA 510(k)

ORION DIAGNOSTICA UNIQ PINP RIA

K-Number: K043125 · 2005-05-04

ApplicantOrion Diagnostica, OY
Decision Date2005-05-04
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORION DIAGNOSTICA UNIQ PINP RIA is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, OY. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K043125. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION DIAGNOSTICA UNIQ PINP RIA?

ORION DIAGNOSTICA UNIQ PINP RIA is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Orion Diagnostica, OY. The 510(k) number is K043125.

When did ORION DIAGNOSTICA UNIQ PINP RIA receive FDA 510(k) clearance?

ORION DIAGNOSTICA UNIQ PINP RIA received FDA 510(k) clearance on 2005-05-04, under 510(k) number K043125.

Who is the listed applicant for ORION DIAGNOSTICA UNIQ PINP RIA?

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

What is the FDA product code for ORION DIAGNOSTICA UNIQ PINP RIA?

The FDA product code for ORION DIAGNOSTICA UNIQ PINP RIA is CIN.

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Other records listing Orion Diagnostica, OY 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.

K142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentK042625QUIKREAD CRP CALIBRATOR SETK042442QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

Related Devices (Code: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.K981373ALKPHASE-B ASSAY KITMetra Biosystems, 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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