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FDA 510(k)

READS(R) ANTI-ENA (SM/RNP) TEST KIT

K-Number: K901924 · 1990-05-09

ApplicantBiosearch Medical Products, Inc.
Decision Date1990-05-09
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

READS(R) ANTI-ENA (SM/RNP) TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K901924. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the READS(R) ANTI-ENA (SM/RNP) TEST KIT?

READS(R) ANTI-ENA (SM/RNP) TEST KIT is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K901924.

When did READS(R) ANTI-ENA (SM/RNP) TEST KIT receive FDA 510(k) clearance?

READS(R) ANTI-ENA (SM/RNP) TEST KIT received FDA 510(k) clearance on 1990-05-09, under 510(k) number K901924.

Who is the listed applicant for READS(R) ANTI-ENA (SM/RNP) TEST KIT?

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

What is the FDA product code for READS(R) ANTI-ENA (SM/RNP) TEST KIT?

The FDA product code for READS(R) ANTI-ENA (SM/RNP) TEST KIT is LLL.

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Other records listing Biosearch Medical Products, Inc. as applicant

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Related Devices (Code: LLL)

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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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