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FDA 510(k)

SPQ CRP CONTROL LEVEL II

K-Number: K935075 · 1994-01-11

ApplicantIncstar Corp.
Decision Date1994-01-11
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ CRP CONTROL LEVEL II is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1994-01-11 under 510(k) number K935075. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ CRP CONTROL LEVEL II?

SPQ CRP CONTROL LEVEL II is a medical device that received FDA 510(k) clearance on 1994-01-11. The listed applicant is Incstar Corp.. The 510(k) number is K935075.

When did SPQ CRP CONTROL LEVEL II receive FDA 510(k) clearance?

SPQ CRP CONTROL LEVEL II received FDA 510(k) clearance on 1994-01-11, under 510(k) number K935075.

Who is the listed applicant for SPQ CRP CONTROL LEVEL II?

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

What is the FDA product code for SPQ CRP CONTROL LEVEL II?

The FDA product code for SPQ CRP CONTROL LEVEL II is DCN.

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Other records listing Incstar 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960367INCSTAR RUBELLA IGG ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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