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FDA 510(k)

ALP (OPT) REAGENT

K-Number: K862905 · 1986-08-29

ApplicantSigma Diagnostics, Inc.
Decision Date1986-08-29
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALP (OPT) REAGENT 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 1986-08-29 under 510(k) number K862905. 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 ALP (OPT) REAGENT?

ALP (OPT) REAGENT is a medical device that received FDA 510(k) clearance on 1986-08-29. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K862905.

When did ALP (OPT) REAGENT receive FDA 510(k) clearance?

ALP (OPT) REAGENT received FDA 510(k) clearance on 1986-08-29, under 510(k) number K862905.

Who is the listed applicant for ALP (OPT) REAGENT?

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 ALP (OPT) REAGENT?

The FDA product code for ALP (OPT) REAGENT is CJE.

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Other records listing Sigma Diagnostics, 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.

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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