Gmate® Control Solution Level 3 PC-003

• FDA 510(k) K113636 decided 8 Mar 2013 Active
• FDA GUDID UDI-DI 08809301162026 listed 6 Jun 2017 Listed

1. 8 Mar 2013 Cleared FDA 510(k) K113636
2. 6 Jun 2017 Listed FDA GUDID 08809301162026

Trade name

Gmate® Control Solution Level 3

Generic name

Glucose monitoring system IVD, home-use

Model / reference

PC-003

Primary DI / UDI-DI

08809301162026

510(k) Number

K113636 ↗

FDA product code

JJX

GMDN term

Glucose monitoring system IVD, home-use

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Glucose monitoring system IVD, home-use

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

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• HCG CONTROL KIT by Monoclonal Antibodies, Inc.

• Gmate® Origin Blood Glucose Monitoring System PG-310

  Class II

  FDA 510(k) K151658 Active Cleared 1 Dec 2015 GUDID on market

• Gmate® SMART Blood Glucose Monitoring System PG-101

  Class II

  FDA 510(k) K150299 Active Cleared 19 Nov 2015 GUDID on market

• Gmate® VOICE Blood Glucose Monitoring System PG-301

  Class II

  FDA 510(k) K113636 Active Cleared 8 Mar 2013 GUDID on market

• Gmate® Control Solution Level 2 PC-002

  Class I

  FDA 510(k) K113636 Active Cleared 8 Mar 2013 GUDID on market

See all devices from Philosys, Inc. →