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FDA 510(k)

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY

K-Number: K852033 · 1985-06-21

ApplicantMeloy Laboratories, Inc.
Decision Date1985-06-21
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Meloy Laboratories, Inc.. It received FDA 510(k) clearance on 1985-06-21 under 510(k) number K852033. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SS-A(RO) & SS-B(LA) ANTIBODY ASSAY?

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1985-06-21. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K852033.

When did SS-A(RO) & SS-B(LA) ANTIBODY ASSAY receive FDA 510(k) clearance?

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY received FDA 510(k) clearance on 1985-06-21, under 510(k) number K852033.

Who is the listed applicant for SS-A(RO) & SS-B(LA) ANTIBODY ASSAY?

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

What is the FDA product code for SS-A(RO) & SS-B(LA) ANTIBODY ASSAY?

The FDA product code for SS-A(RO) & SS-B(LA) ANTIBODY ASSAY is DHN.

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Other records listing Meloy Laboratories, Inc. as applicant

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Related Devices (Code: DHN)

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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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