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FDA 510(k)

RHEUMELISA II SCL-70 ANTIBODY TEST KIT

K-Number: K930130 · 1993-03-23

ApplicantBiowhittaker Molecular Applications, Inc.
Decision Date1993-03-23
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMELISA II SCL-70 ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biowhittaker Molecular Applications, Inc.. It received FDA 510(k) clearance on 1993-03-23 under 510(k) number K930130. 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 RHEUMELISA II SCL-70 ANTIBODY TEST KIT?

RHEUMELISA II SCL-70 ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Biowhittaker Molecular Applications, Inc.. The 510(k) number is K930130.

When did RHEUMELISA II SCL-70 ANTIBODY TEST KIT receive FDA 510(k) clearance?

RHEUMELISA II SCL-70 ANTIBODY TEST KIT received FDA 510(k) clearance on 1993-03-23, under 510(k) number K930130.

Who is the listed applicant for RHEUMELISA II SCL-70 ANTIBODY TEST KIT?

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

What is the FDA product code for RHEUMELISA II SCL-70 ANTIBODY TEST KIT?

The FDA product code for RHEUMELISA II SCL-70 ANTIBODY TEST KIT is LLL.

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Other records listing Biowhittaker Molecular Applications, 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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