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FDA 510(k)

DECALCIFIER SOLUTION

K-Number: K842726 · 1984-08-03

ApplicantE K Ind., Inc.
Decision Date1984-08-03
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

DECALCIFIER SOLUTION 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 1984-08-03 under 510(k) number K842726. The device is classified under product code KDX. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECALCIFIER SOLUTION?

DECALCIFIER SOLUTION is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is E K Ind., Inc.. The 510(k) number is K842726.

When did DECALCIFIER SOLUTION receive FDA 510(k) clearance?

DECALCIFIER SOLUTION received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842726.

Who is the listed applicant for DECALCIFIER SOLUTION?

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 DECALCIFIER SOLUTION?

The FDA product code for DECALCIFIER SOLUTION is KDX.

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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: KDX)

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.

K872625DECALCIFYING SOLUTIONStephens ScientificK850636SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-EFisher Scientific Co., LLCK841488DECALCIFIER ISurgipath Medical Industries, Inc.K822036VOLU-SOL DECALCIFERVolu Sol Medical IndustriesK821443FORMICALLerner Laboratories, Inc.K811801CAL-RITERichard-Allan Medical Ind., Inc.

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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