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FDA 510(k)

FORMICAL

K-Number: K821443 · 1982-06-02

ApplicantLerner Laboratories, Inc.
Decision Date1982-06-02
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

FORMICAL is the device name listed in this FDA 510(k) record. The listed applicant is Lerner Laboratories, Inc.. It received FDA 510(k) clearance on 1982-06-02 under 510(k) number K821443. 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 FORMICAL?

FORMICAL is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Lerner Laboratories, Inc.. The 510(k) number is K821443.

When did FORMICAL receive FDA 510(k) clearance?

FORMICAL received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821443.

Who is the listed applicant for FORMICAL?

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

What is the FDA product code for FORMICAL?

The FDA product code for FORMICAL is KDX.

Related Clinical Trials

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.

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Other records listing Lerner Laboratories, 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.

K854083XYLENE SUBSTITUTE MONTANTK853694XYLENE SUBSTITUTEK761000PAP-TRAY I (CATALOG #C600-1)K761001PAP-TRAY II (CATALOG #C600-2)

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., LLCK842726DECALCIFIER SOLUTIONE K Ind., Inc.K841488DECALCIFIER ISurgipath Medical Industries, Inc.K822036VOLU-SOL DECALCIFERVolu Sol Medical IndustriesK811801CAL-RITERichard-Allan Medical Ind., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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