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FDA 510(k)

AEC DETECTION KIT

K-Number: K920566 · 1992-05-08

ApplicantVentana Medical Systems, Inc.
Decision Date1992-05-08
Product CodeDEY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AEC DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-05-08 under 510(k) number K920566. The device is classified under product code DEY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEC DETECTION KIT?

AEC DETECTION KIT is a medical device that received FDA 510(k) clearance on 1992-05-08. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K920566.

When did AEC DETECTION KIT receive FDA 510(k) clearance?

AEC DETECTION KIT received FDA 510(k) clearance on 1992-05-08, under 510(k) number K920566.

Who is the listed applicant for AEC DETECTION KIT?

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

What is the FDA product code for AEC DETECTION KIT?

The FDA product code for AEC DETECTION KIT is DEY.

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Other records listing Ventana Medical Systems, 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.

K242783Roche Digital Pathology DxK232879Roche Digital Pathology Dx (VENTANA DP 200)K212176CINtec HistologyK172471VENTANA CD30 (Ber-H2) RxDx AssayK130515VIRTUOSO SYSTEM FOR IHC ER (SPI)K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

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Related Devices (Code: DEY)

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.

K932386VENTANA RED DETECTION KITVentana Medical Systems, Inc.K920600DAB DETECTION KITVentana Medical Systems, 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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