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FDA 510(k)

QUIKREAD CRP CALIBRATOR SET

K-Number: K042625 · 2004-11-18

ApplicantOrion Diagnostica, OY
Decision Date2004-11-18
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIKREAD CRP CALIBRATOR SET 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 2004-11-18 under 510(k) number K042625. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKREAD CRP CALIBRATOR SET?

QUIKREAD CRP CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2004-11-18. The listed applicant is Orion Diagnostica, OY. The 510(k) number is K042625.

When did QUIKREAD CRP CALIBRATOR SET receive FDA 510(k) clearance?

QUIKREAD CRP CALIBRATOR SET received FDA 510(k) clearance on 2004-11-18, under 510(k) number K042625.

Who is the listed applicant for QUIKREAD CRP CALIBRATOR SET?

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 QUIKREAD CRP CALIBRATOR SET?

The FDA product code for QUIKREAD CRP CALIBRATOR SET is JJY.

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 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 InstrumentK043125ORION DIAGNOSTICA UNIQ PINP RIAK042442QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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