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FDA 510(k)

GRAM IODINE

K-Number: K842733 · 1984-08-10

ApplicantE K Ind., Inc.
Decision Date1984-08-10
Product CodeHYI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GRAM IODINE 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 1984-08-10 under 510(k) number K842733. The device is classified under product code HYI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM IODINE?

GRAM IODINE is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is E K Ind., Inc.. The 510(k) number is K842733.

When did GRAM IODINE receive FDA 510(k) clearance?

GRAM IODINE received FDA 510(k) clearance on 1984-08-10, under 510(k) number K842733.

Who is the listed applicant for GRAM IODINE?

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 GRAM IODINE?

The FDA product code for GRAM IODINE is HYI.

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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: HYI)

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.

K871286GRAM IODINERemel Co.K821977GRAMSTAIN SETGranite Diagnostics, Inc.K811722PARA-PAKMeridian Diagnostics, Inc.K791711IMPROVED GRAM STAIN REAGENTSCarr-Scarborough Microbiologicals, Inc.K781584GRAM STAIN KITBioscientific

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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