Spotcheck 80-0900P4K

• FDA 510(k) K090940 decided 14 Dec 2009 Active
• FDA GUDID UDI-DI 00725609000441 listed 14 Oct 2016 Listed

1. 14 Dec 2009 Cleared FDA 510(k) K090940
2. 14 Oct 2016 Listed FDA GUDID 00725609000441

Trade name

Spotcheck

Generic name

Multiple clinical chemistry enzyme IVD, control

Model / Ref / Catalog

80-0900P4K

Primary DI / UDI-DI

00725609000441

510(k) Number

K090940 ↗

FDA product code

JJT

GMDN term

Multiple clinical chemistry enzyme IVD, control

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Multiple clinical chemistry enzyme IVD, control

Other devices filed under FDA product code JJT (Enzyme Controls (Assayed And Unassayed)).

• CARDIOZYME CK CONTROL NORMAL by Dade, Baxter Travenol Diagnostics, Inc.
• QUANTEX ASO-CRP-RP CONTROL II by INSTRUMENTATION LABORATORY COMPANY
• DADE TRU-LIQUID CARDIAC CONTROL by Dade Intl., Inc.
• CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL by Cliniqa Corporation
• CARDIOISOZYME, CK/LD ISOENZYME CONTROL by Medical Analysis Systems, Inc.
• U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL by U.S. DIAGNOSTICS INC.
• U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL by U.S. DIAGNOSTICS INC.
• CARDIO REP LD CONTROL - CAT NO. 3325 by Helena Laboratories, Corp.
• ID-ZONE LD ISOENZYME CONTROL by Beckman Instruments, Inc.
• CK-MB/LD-1 CONTROL SYSTEM by Boehringer Mannheim Corp.

• Spotcheck 80-3500-13K

  Class II

  FDA 510(k) K990957 Active Cleared 11 May 1999 GUDID on market

• Spotcheck 80-0900-01K

  Class I

  FDA 510(k) K090940 Active Cleared 14 Dec 2009 GUDID on market

• Spotcheck 307-A001-02

  Class I

  FDA 510(k) K101392 Active Cleared 4 Feb 2011 GUDID on market

• Spotcheck 303-A980-00B

  Class I

  FDA 510(k) K883020 Active Cleared 2 Sep 1988 GUDID on market

See all devices from Astoria-Pacific, Inc. →