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FDA 510(k)

SIGMA PROCED. 245 ALKALINE PHOSPHATASE

K-Number: K841918 · 1984-06-14

ApplicantSigma Diagnostics, Inc.
Decision Date1984-06-14
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCED. 245 ALKALINE PHOSPHATASE is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-06-14 under 510(k) number K841918. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA PROCED. 245 ALKALINE PHOSPHATASE?

SIGMA PROCED. 245 ALKALINE PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1984-06-14. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K841918.

When did SIGMA PROCED. 245 ALKALINE PHOSPHATASE receive FDA 510(k) clearance?

SIGMA PROCED. 245 ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1984-06-14, under 510(k) number K841918.

Who is the listed applicant for SIGMA PROCED. 245 ALKALINE PHOSPHATASE?

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

What is the FDA product code for SIGMA PROCED. 245 ALKALINE PHOSPHATASE?

The FDA product code for SIGMA PROCED. 245 ALKALINE PHOSPHATASE is CJE.

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Other records listing Sigma Diagnostics, Inc. as applicant

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K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: CJE)

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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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