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FDA 510(k)

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)

K-Number: K893036 · 1989-06-02

ApplicantAmersham Corp.
Decision Date1989-06-02
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-06-02 under 510(k) number K893036. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)?

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) is a medical device that received FDA 510(k) clearance on 1989-06-02. The listed applicant is Amersham Corp.. The 510(k) number is K893036.

When did ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) receive FDA 510(k) clearance?

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) received FDA 510(k) clearance on 1989-06-02, under 510(k) number K893036.

Who is the listed applicant for ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)?

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 ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)?

The FDA product code for ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) is LRM.

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Other records listing Amersham Corp. as applicant

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Related Devices (Code: LRM)

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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