Echo Type 11 CF Antigen

FDA 510(k) K853157 · Hillcrest Biologicals

Substantially Equivalent

510(k) numberK853157

Submission

Device name
Echo Type 11 CF Antigen
Applicant
Hillcrest Biologicals
Cypress, CA, US
Received
July 30, 1985
Decision date
November 7, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GNK – Antisera, Cf, Echovirus 1-34
Device class
Class I (low risk)
Regulation
21 CFR 866.3205
Specialty
Microbiology

Other 510(k)s with product code GNK

510(k)DeviceApplicantDecision
K853165Echo Type 30 CF AntigenGNK · Traditional Hillcrest Biologicals11/07/1985SE
K853156Echo Type 16 CF AntigenGNK · Traditional Hillcrest Biologicals11/07/1985SE

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K922374Q Fever Igm Ifa TestGPJ · Traditional 10/21/1992SE
K913906Q Fever Igg Ifa TestGPJ · Traditional 10/21/1992SE
K900206Lyme Disease Igm ElisaLSR · Traditional 06/28/1991SE
K896594Ebv Vca Antibody (Igm)LJN · Traditional 01/16/1990SE
K884829Ebv Early Antigen (R+D)JRY · Traditional 04/12/1989SE
K883767Lyme Disease Ifa (Igm)LSR · Traditional 03/15/1989SE
K884591Ebv-Vca Antibody (Igg)GNP · Traditional 01/24/1989SE
K883487Lyme Disease Ifa (Igg)LSR · Traditional 12/13/1988SE

Questions and answers

When was Echo Type 11 CF Antigen cleared by the FDA?

Echo Type 11 CF Antigen (K853157) received a 510(k) decision of Substantially Equivalent on November 7, 1985, 100 days after the submission was received.

What is the product code of K853157?

The FDA product code is GNK – Antisera, Cf, Echovirus 1-34, a Class I (low risk) device regulated under 21 CFR 866.3205.