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FDA 510(k)

DYNASTY GC 12550 (GELL/CELL)

K-Number: K942310 · 1994-11-07

Decision Date1994-11-07
Product CodeKNN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNASTY GC 12550 (GELL/CELL) is the device name listed in this FDA 510(k) record. The listed applicant is Foley & Lardner. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K942310. The device is classified under product code KNN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNASTY GC 12550 (GELL/CELL)?

DYNASTY GC 12550 (GELL/CELL) is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Foley & Lardner. The 510(k) number is K942310.

When did DYNASTY GC 12550 (GELL/CELL) receive FDA 510(k) clearance?

DYNASTY GC 12550 (GELL/CELL) received FDA 510(k) clearance on 1994-11-07, under 510(k) number K942310.

Who is the listed applicant for DYNASTY GC 12550 (GELL/CELL)?

The FDA 510(k) record lists Foley & Lardner as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNASTY GC 12550 (GELL/CELL)?

The FDA product code for DYNASTY GC 12550 (GELL/CELL) is KNN.

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.

Other records listing Foley & Lardner 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.

Related Devices (Code: KNN)

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.

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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