Poly stat HCG-POC

• FDA 510(k) K921206 decided 29 Apr 1992 Active
• FDA GUDID UDI-DI 00855574005377 listed 23 Sep 2016 Listed

1. 29 Apr 1992 Cleared FDA 510(k) K921206
2. 23 Sep 2016 Listed FDA GUDID 00855574005377

Trade name

Poly stat

Generic name

Human chorionic gonadotropin alpha-subunit IVD, control

Model / reference

HCG-POC

Primary DI / UDI-DI

00855574005377

510(k) Number

K921206 ↗

FDA product code

JJX

GMDN term

Human chorionic gonadotropin alpha-subunit IVD, control

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Human chorionic gonadotropin alpha-subunit IVD, control

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See all devices from Polymedco, Inc. →