Hcg Control

510(k) Number

K921206 ↗

FDA product code

JJX

Device class

Class I

Regulation

21 CFR Part 862.1660

Advisory committee

Clinical Chemistry

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• ELECSYS PRECICONTROL TS by Roche Diagnostics Corp.
• ADVIA Centaur® ACS:180® Calibrator A 10285904 4800735 by Siemens Healthcare Diagnostics Inc.
• ELECSYS PARATHYROID HORMONE CALCHECK by Roche Diagnostics Corp.
• LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 by Bio-Rad
• BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE by Cliniqa Corporation
• HemosIL AcuStar Anti-B2GPI Domain 1 Controls 00009800022 by INSTRUMENTATION LABORATORY COMPANY
• CARDIAC STATUS CONTROLS/TROPONIN I by Spectral Diagnostics, Inc.
• Atellica IM Herpes-2 IgG Quality Control 10733034 by Siemens Healthcare Diagnostics Inc.
• LIBERTY NORMAL GLUCOSE CONTROL SOLUTION by Liberty Healthcare Group, Inc.
• DOCUMENT CHEM III CALIBRATION VERIFICATION TEST by Casco Standards

• C-Reactive Protein (Crp) Agglutination Latex Kit

  Class II

  FDA 510(k) K962049 Active Cleared 18 Dec 1996

• Poly stat STS25

  Class I

  FDA 510(k) K040708 Active Cleared 22 Nov 2004 GUDID on market

• Poly stat HCG-POC

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• Poly stat FLU25

  Class I

  FDA 510(k) K132465 Active Cleared 9 Sep 2013 GUDID on market

See all devices from Polymedco, Inc. →