Spotcheck 80-0900-01K

• FDA 510(k) K090940 decided 14 Dec 2009 Active
• FDA GUDID UDI-DI 00725609000205 listed 14 Oct 2016 Listed

1. 14 Dec 2009 Cleared FDA 510(k) K090940
2. 14 Oct 2016 Listed FDA GUDID 00725609000205

Trade name

Spotcheck

Generic name

Multiple clinical chemistry enzyme IVD, control

Model / Ref / Catalog

80-0900-01K

Primary DI / UDI-DI

00725609000205

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)).

• CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ by Cala Diagnostics
• CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1, 2, 3, MODELS NUMBER 175-1, 175-2, 175-3 by MORE DIAGNOSTICS INC
• CLIN. CHEM. CONTROL SERUM-QUANTITATE by Beckman Instruments, Inc.
• CARDIOZYME CK-CONTROL ABNORMAL by Dade, Baxter Travenol Diagnostics, Inc.
• PATHONORM H & L by Nyegaard & Co. A/S
• CARDIASURE CARDIAC MARKERS CONTROL by QUANTIMETRIX CORP.
• ISOTRAK AMYLASE ISOENZYME CONTROL SET by Behring Diagnostics, Inc.
• DELTA TROL I & II by Electro-Nucleonics Laboratories, Inc.
• CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION by Clinical Controls, Inc.
• HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) by Hichem Diagnostics

• Spotcheck 80-3500-13K

  Class II

  FDA 510(k) K990957 Active Cleared 11 May 1999 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

• Spotcheck 303-A003-03

  Class I

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

See all devices from Astoria-Pacific, Inc. →