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FDA 510(k)

NEW METHYLENE BLUE N

K-Number: K842743 · 1984-08-12

ApplicantE K Ind., Inc.
Decision Date1984-08-12
Product CodeKFC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NEW METHYLENE BLUE N is the device name listed in this FDA 510(k) record. The listed applicant is E K Ind., Inc.. It received FDA 510(k) clearance on 1984-08-12 under 510(k) number K842743. The device is classified under product code KFC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW METHYLENE BLUE N?

NEW METHYLENE BLUE N is a medical device that received FDA 510(k) clearance on 1984-08-12. The listed applicant is E K Ind., Inc.. The 510(k) number is K842743.

When did NEW METHYLENE BLUE N receive FDA 510(k) clearance?

NEW METHYLENE BLUE N received FDA 510(k) clearance on 1984-08-12, under 510(k) number K842743.

Who is the listed applicant for NEW METHYLENE BLUE N?

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

What is the FDA product code for NEW METHYLENE BLUE N?

The FDA product code for NEW METHYLENE BLUE N is KFC.

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Other records listing E K Ind., 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.

K842931DRABKIN REAGENTK842938ACETIC ACID 1% V/VK842934DECOLORIZING FLUIC, ACID-ALCOHOL 3%K842937ACETIC ACID 2% V/VK842935ACETIC ACID, 5% V/VK842936ACETIC ACID, 3% V/V

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Related Devices (Code: KFC)

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.

K875310RETICULOCYTE STAINSigma Diagnostics, Inc.K843919SPOTTEST LOEFFLER METHYLENE BLUE STAINDifco Laboratories, Inc.K842785STAIN, METHYLENE BLUE-EOSINReagent Laboratory, Inc.K842926METHYLENE BLUE STAIN, LOEFFLERE K Ind., Inc.K831502NEPHROLYTEFlaitron Laboratories, Inc.K770792TUBE, STAIN, RETICULOCYTE, LARCCorning Medical & Scientific

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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