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FDA 510(k)

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E

K-Number: K850636 · 1985-03-20

ApplicantFisher Scientific Co., LLC
Decision Date1985-03-20
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1985-03-20 under 510(k) number K850636. 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 SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E?

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E is a medical device that received FDA 510(k) clearance on 1985-03-20. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K850636.

When did SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E receive FDA 510(k) clearance?

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E received FDA 510(k) clearance on 1985-03-20, under 510(k) number K850636.

Who is the listed applicant for SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E?

The FDA product code for SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E is KDX.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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 ScientificK842726DECALCIFIER SOLUTIONE K Ind., Inc.K841488DECALCIFIER 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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