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FDA 510(k)

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL

K-Number: K894329 · 1989-09-05

ApplicantAmersham Corp.
Decision Date1989-09-05
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894329. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL?

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Amersham Corp.. The 510(k) number is K894329.

When did RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL receive FDA 510(k) clearance?

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894329.

Who is the listed applicant for RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL?

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

What is the FDA product code for RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL?

The FDA product code for RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL is JJX.

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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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