Piccolo(Tm)

• • Terminated Z-1155-2010 FDA Unclassified (pre-2012) ·initiated 16 Nov 2009 ·on shared 510(k) K942782

  Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 13 Mar 1995 Cleared FDA 510(k) K942782
2. 16 Nov 2009 Recall initiated FDA recalls Z-1155-2010

510(k) Number

K942782 ↗

FDA product code

JJG

Device class

Class I

Regulation

21 CFR Part 862.2140

Advisory committee

Clinical Chemistry

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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 JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use).

• COBAS FARA CENTRIFUGAL ANALYZER by Roche Diagnostic Systems, Inc.
• COBAS ALPHA by Roche Diagnostic Systems, Inc.
• ANALYST PHYSICIAN'S OFFICE PROFILER by E.I. Dupont DE Nemours & Co., Inc.
• COBAS-BIO CENTRIFUGAL ANALYZER by Hoffmann-La Roche, Inc.
• ENCORE CHEMISTRY ANALYZER by Baker Instructions Corp.
• FLEXIGRAM AUTO LOADER SYSTEM by Electro-Nucleonics Laboratories, Inc.
• GEN PROFILER SYSTEM by Electro-Nucleonics, Inc.
• CENTRIFICHEM SYS 400 ANALYZER by Clinical Diagnostics, Inc.
• OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER by Olympus Corp.
• TECHNICON DAX(TM) SYSTEM by Technicon Instruments Corp.

• Piccolo Hepatic Function Panel 400-0026

  Class II

  FDA 510(k) ×3 Active Cleared 6 Apr 1994 GUDID on market

• Piccolo Comprehensive Metabolic Panel 400-0028

  Class II

  FDA 510(k) ×6 Active Cleared 26 Apr 2001 GUDID on market

• Piccolo Renal Function Panel 400-0027

  Class I

  FDA 510(k) ×7 Active Cleared 26 Apr 2001 GUDID on market

• Piccolo Kidney Check 400-0033

  Class II

  FDA 510(k) K942782 Active Cleared 13 Mar 1995 GUDID on market

See all devices from Abaxis, Inc. →