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FDA 510(k)

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

K-Number: K063647 · 2007-03-12

ApplicantThermo Electron OY
Decision Date2007-03-12
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Electron OY. It received FDA 510(k) clearance on 2007-03-12 under 510(k) number K063647. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH?

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH is a medical device that received FDA 510(k) clearance on 2007-03-12. The listed applicant is Thermo Electron OY. The 510(k) number is K063647.

When did CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH receive FDA 510(k) clearance?

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH received FDA 510(k) clearance on 2007-03-12, under 510(k) number K063647.

Who is the listed applicant for CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH?

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

What is the FDA product code for CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH?

The FDA product code for CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH is NDY.

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Other records listing Thermo Electron 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.

K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSK063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSK063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHK063086TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLSK063209HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

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Related Devices (Code: NDY)

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.

K242585Cystatin CSENTINEL CH. SpAK181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbHK161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)K111664DIAZYME CYSTATIN C POC TEST KITDiazyme LaboratoriesK093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLKamiya Biomedical Co.

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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