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FDA 510(k)

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

K-Number: K760591 · 1976-10-29

ApplicantSigma Chemical Co.
Decision Date1976-10-29
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1976-10-29 under 510(k) number K760591. 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 SIGMA PROCEDURE NO. 745 - EP.REAGENT SY?

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY is a medical device that received FDA 510(k) clearance on 1976-10-29. The listed applicant is Sigma Chemical Co.. The 510(k) number is K760591.

When did SIGMA PROCEDURE NO. 745 - EP.REAGENT SY receive FDA 510(k) clearance?

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY received FDA 510(k) clearance on 1976-10-29, under 510(k) number K760591.

Who is the listed applicant for SIGMA PROCEDURE NO. 745 - EP.REAGENT SY?

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

What is the FDA product code for SIGMA PROCEDURE NO. 745 - EP.REAGENT SY?

The FDA product code for SIGMA PROCEDURE NO. 745 - EP.REAGENT SY is JHX.

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Other records listing Sigma Chemical Co. as applicant

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K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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