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FDA 510(k)

METHYLENE BLUE STAIN, LOEFFLER

K-Number: K842926 · 1984-09-11

ApplicantE K Ind., Inc.
Decision Date1984-09-11
Product CodeKFC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

METHYLENE BLUE STAIN, LOEFFLER 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 1984-09-11 under 510(k) number K842926. 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 METHYLENE BLUE STAIN, LOEFFLER?

METHYLENE BLUE STAIN, LOEFFLER is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is E K Ind., Inc.. The 510(k) number is K842926.

When did METHYLENE BLUE STAIN, LOEFFLER receive FDA 510(k) clearance?

METHYLENE BLUE STAIN, LOEFFLER received FDA 510(k) clearance on 1984-09-11, under 510(k) number K842926.

Who is the listed applicant for METHYLENE BLUE STAIN, LOEFFLER?

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 METHYLENE BLUE STAIN, LOEFFLER?

The FDA product code for METHYLENE BLUE STAIN, LOEFFLER 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.K842743NEW METHYLENE BLUE NE 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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