GNK · Class I · 21 CFR 866.3205

FDA Product Code GNK: Antisera, Cf, Echovirus 1-34

Leading manufacturers include Hillcrest Biologicals.

3

Total

3

Cleared

100d

Avg days

1985

Since

FDA 510(k) Cleared Antisera, Cf, Echovirus 1-34 Devices (Product Code GNK)

3 devices

1–3 of 3

Cleared Nov 07, 1985

ECHO TYPE 16 CF ANTIGEN

Hillcrest Biologicals

Microbiology · 100d

Cleared Nov 07, 1985

ECHO TYPE 11 CF ANTIGEN

Hillcrest Biologicals

Microbiology · 100d

Cleared Nov 07, 1985

ECHO TYPE 30 CF ANTIGEN

Hillcrest Biologicals

Microbiology · 100d

About Product Code GNK - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Nov 07, 1985

Product Code Info

Code	GNK
Device class	Class I
CFR	21 CFR 866.3205
Panel	Microbiology

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View GNK classification on FDA.gov →