Viral Antisera, Fluorescein Labeled

FDA 510(k) K770216 · Flow Laboratories, Inc.

Substantially Equivalent

510(k) numberK770216

Submission

Device name
Viral Antisera, Fluorescein Labeled
Applicant
Flow Laboratories, Inc.
Mchenry, IL, US
Received
February 2, 1977
Decision date
March 1, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GRA – Antiserum, Fluorescent, Mumps Virus
Device class
Class I (low risk)
Regulation
21 CFR 866.3380
Specialty
Microbiology

Other 510(k)s with product code GRA

510(k)DeviceApplicantDecision
K894624Mumps VirusGRA · Traditional Bion Ent., Ltd.10/16/1989SE
K822826Antibody to Mumps Virus Ifa TestGRA · Traditional Electro-Nucleonics Laboratories, Inc.12/03/1982SE

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Questions and answers

When was Viral Antisera, Fluorescein Labeled cleared by the FDA?

Viral Antisera, Fluorescein Labeled (K770216) received a 510(k) decision of Substantially Equivalent on March 1, 1977, 27 days after the submission was received.

What is the product code of K770216?

The FDA product code is GRA – Antiserum, Fluorescent, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.