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FDA 510(k)

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE

K-Number: K801318 · 1980-07-14

ApplicantHelena Laboratories
Decision Date1980-07-14
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801318. 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 HELENA ULTRA SENSITIVE CPK REAGENT/DILUE?

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Helena Laboratories. The 510(k) number is K801318.

When did HELENA ULTRA SENSITIVE CPK REAGENT/DILUE receive FDA 510(k) clearance?

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801318.

Who is the listed applicant for HELENA ULTRA SENSITIVE CPK REAGENT/DILUE?

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

What is the FDA product code for HELENA ULTRA SENSITIVE CPK REAGENT/DILUE?

The FDA product code for HELENA ULTRA SENSITIVE CPK REAGENT/DILUE is JHX.

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Other records listing Helena Laboratories 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.

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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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