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FDA 510(k)

CREATINE KINASE (CK) REAGENT SET

K-Number: K881237 · 1988-04-28

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-04-28
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE (CK) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K881237. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE (CK) REAGENT SET?

CREATINE KINASE (CK) REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K881237.

When did CREATINE KINASE (CK) REAGENT SET receive FDA 510(k) clearance?

CREATINE KINASE (CK) REAGENT SET received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881237.

Who is the listed applicant for CREATINE KINASE (CK) REAGENT SET?

The FDA 510(k) record lists Tech-Neal Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE (CK) REAGENT SET?

The FDA product code for CREATINE KINASE (CK) REAGENT SET is JHX.

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Other records listing Tech-Neal Scientific, Inc. 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.

K882256MAGNESIUM REAGENT SETK882459DIAZO, COLORIMETRIC BILIRUBINK881239GAMMA GLUTAMYL TRANSFERASE REAGENT SETK881241TOTAL BILIRUBIN REAGENTK881240CHLORIDE REAGENT SETK880237CHOLESTEROL

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Related Devices (Code: JHX)

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.

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical ApsK120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical ApsK081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku IatronK051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, 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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