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FDA 510(k)

RADIOLOGICAL MARKING PEN

K-Number: K852160 · 1985-07-18

ApplicantTruett Laboratories, Inc.
Decision Date1985-07-18
Product CodeJAC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOLOGICAL MARKING PEN is the device name listed in this FDA 510(k) record. The listed applicant is Truett Laboratories, Inc.. It received FDA 510(k) clearance on 1985-07-18 under 510(k) number K852160. The device is classified under product code JAC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOLOGICAL MARKING PEN?

RADIOLOGICAL MARKING PEN is a medical device that received FDA 510(k) clearance on 1985-07-18. The listed applicant is Truett Laboratories, Inc.. The 510(k) number is K852160.

When did RADIOLOGICAL MARKING PEN receive FDA 510(k) clearance?

RADIOLOGICAL MARKING PEN received FDA 510(k) clearance on 1985-07-18, under 510(k) number K852160.

Who is the listed applicant for RADIOLOGICAL MARKING PEN?

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

What is the FDA product code for RADIOLOGICAL MARKING PEN?

The FDA product code for RADIOLOGICAL MARKING PEN is JAC.

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Related Devices (Code: JAC)

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.

K942883DIGITAL I.D. CAMERAMiles Inc., Agfa DivisionK930752CT/MRI TOPOGRAPHIC MARKERI.Z.I. Corp.K932357FUJI EC ID CAMERAFujifilm Medical System U.S.A., Inc.K925892SOLSTICE XRAY RING MARKER PADSolstice Corp.K923533ADMARKPlanmeca USA, Inc.K926404KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4LEastman Kodak Company

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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