Rubeola Test

FDA 510(k) K884004 · Gull Laboratories, Inc.

Substantially Equivalent

510(k) numberK884004

Submission

Device name
Rubeola Test
Applicant
Gull Laboratories, Inc.
Salt Lake City, UT, US
Received
September 21, 1988
Decision date
December 5, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GRE – Antiserum, Fluorescent, Rubeola
Device class
Class I (low risk)
Regulation
21 CFR 866.3520
Specialty
Microbiology

Other 510(k)s with product code GRE

510(k)DeviceApplicantDecision
K853067Fiax Test Kit for Measles-G Antibodies FlyorescentGRE · Traditional Idt, A Division of Whittaker M.A. Bioproducts10/22/1985SE
K821249Eni Antibody to Measles(Rubeola) VirusGRE · Traditional Electro-Nucleonics Laboratories, Inc.07/30/1982SE
K770687Measlesvirus Floure. Conjugated AntiseruGRE · Traditional Microbiological Assoc.06/14/1977SE

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Questions and answers

When was Rubeola Test cleared by the FDA?

Rubeola Test (K884004) received a 510(k) decision of Substantially Equivalent on December 5, 1988, 75 days after the submission was received.

What is the product code of K884004?

The FDA product code is GRE – Antiserum, Fluorescent, Rubeola, a Class I (low risk) device regulated under 21 CFR 866.3520.