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FDA 510(k)

RAPID ACID FAST STAIN

K-Number: K864033 · 1986-11-13

ApplicantSigma Diagnostics, Inc.
Decision Date1986-11-13
Product CodeKJY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RAPID ACID FAST STAIN 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 1986-11-13 under 510(k) number K864033. The device is classified under product code KJY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID ACID FAST STAIN?

RAPID ACID FAST STAIN is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K864033.

When did RAPID ACID FAST STAIN receive FDA 510(k) clearance?

RAPID ACID FAST STAIN received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864033.

Who is the listed applicant for RAPID ACID FAST STAIN?

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 RAPID ACID FAST STAIN?

The FDA product code for RAPID ACID FAST STAIN is KJY.

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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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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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