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FDA 510(k)

TRACCELL 2000 SLIDE MAPPING SYSTEM

K-Number: K982786 · 1998-10-16

ApplicantAccumed Intl., Inc.
Decision Date1998-10-16
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRACCELL 2000 SLIDE MAPPING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accumed Intl., Inc.. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K982786. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACCELL 2000 SLIDE MAPPING SYSTEM?

TRACCELL 2000 SLIDE MAPPING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K982786.

When did TRACCELL 2000 SLIDE MAPPING SYSTEM receive FDA 510(k) clearance?

TRACCELL 2000 SLIDE MAPPING SYSTEM received FDA 510(k) clearance on 1998-10-16, under 510(k) number K982786.

Who is the listed applicant for TRACCELL 2000 SLIDE MAPPING SYSTEM?

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

What is the FDA product code for TRACCELL 2000 SLIDE MAPPING SYSTEM?

The FDA product code for TRACCELL 2000 SLIDE MAPPING SYSTEM is JOY.

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Other records listing Accumed Intl., Inc. as applicant

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Related Devices (Code: JOY)

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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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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