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FDA 510(k)

ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040

K-Number: K860453 · 1986-02-19

ApplicantSigma Diagnostics, Inc.
Decision Date1986-02-19
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 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 1986-02-19 under 510(k) number K860453. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040?

ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K860453.

When did ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 receive FDA 510(k) clearance?

ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 received FDA 510(k) clearance on 1986-02-19, under 510(k) number K860453.

Who is the listed applicant for ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040?

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 ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040?

The FDA product code for ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 is JJX.

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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: JJX)

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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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