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Pip Control Solution Low PC001-US

by Philosys, Inc.

Pip Control Solution Low PC001-US is a Class I device made by Philosys, Inc., cleared under FDA 510(k) K151658 on 1 Dec 2015 and listed in FDA GUDID since 11 Sep 2020 (UDI-DI 08809301162194), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K151658

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809301162194 UDI-DI Date11 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151658 Date1 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151658 decided 1 Dec 2015 Active
  • FDA GUDID UDI-DI 08809301162194 listed 11 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151658
  2. Listed FDA GUDID 08809301162194

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pip Control Solution Low
Generic name
Glucose monitoring system IVD, home-use
Model / reference
PC001-US
Primary DI / UDI-DI
08809301162194
510(k) Number
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

Related devices

Category: Glucose monitoring system IVD, home-use

Cleared under the same submission (K151658)

and 8 more cleared under K151658

Similar devices

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

Other devices from Philosys, Inc.

See all devices from Philosys, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)