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RUBAZYME K790976

by Abbott Laboratories 510(k)

Active United States

510(k) K790976

Overview

The RUBAZYME is a Class II device classified as an Antigen, Ha (Including Ha Control), Rubella. It falls under the medical specialty of Microbiology.

This device was authorized by the FDA with a 510(k) clearance (K790976) on August 16, 1979, after being received on May 23, 1979. It was submitted by Abbott Laboratories.

AI-generated from registry data, 5 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790976 Date16 Aug 1979ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 5 Oct 2026)

Specification

510(k)

Full name
Rubazyme
510(k) Number
FDA Product Code
GOL
Device Class
Class II
Regulation
21 CFR Part 866.3510
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the RUBAZYME device?

    The RUBAZYME is a Class II medical device. It is classified as an Antigen, Ha (Including Ha Control), Rubella, and is used within the medical specialty of Microbiology.

  • What is the regulatory status of the RUBAZYME?

    The RUBAZYME was authorized by the FDA with a 510(k) clearance (K790976) on August 16, 1979. This clearance indicates it was found substantially equivalent to a predicate device.

  • Who manufactured the RUBAZYME device?

    The RUBAZYME device was submitted by Abbott Laboratories, located at One Abbott Park Rd., Abbott Park, IL 60064, USA.