Chemistry Reference Kit 9510

• FDA 510(k) K901113 decided 29 Mar 1990 Active
• FDA GUDID UDI-DI 00852553007209 listed 16 Jan 2018 Listed

1. 29 Mar 1990 Cleared FDA 510(k) K901113
2. 16 Jan 2018 Listed FDA GUDID 00852553007209

Trade name

Chemistry Reference Kit

Generic name

Multiple clinical chemistry protein IVD, calibrator

Model / reference

9510

Primary DI / UDI-DI

00852553007209

510(k) Number

K901113 ↗

FDA product code

JIX

GMDN term

Multiple clinical chemistry protein IVD, calibrator

Device class

Class II

Regulation number

862.1150

GUDID distribution status

In Commercial Distribution

Category: Multiple clinical chemistry protein IVD, calibrator

Other devices filed under FDA product code JIX (Calibrator, Multi-Analyte Mixture).

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• Plasma Calibrator Set 92031 by Chromsystems Instruments & Chemicals GmbH
• DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A by Siemens Healthcare Diagnostics
• BIOTROL CALIBRANT LEVEL 1 by Biotrol, USA, Inc.
• INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU by Alpkem Corp.
• ADVIA® Chemistry Microalbumin_2 Calibrators 10337470 6487733 by Siemens Healthcare Diagnostics Inc.
• SALT BRIDGE SOLUTION & URINE DILUENT by Shaban Mfg. Co.
• CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 by Helena Laboratories, Corp.
• LYPHOCHEK SERUM REF. STANDARD-BOVINE by Bio-Rad

• Lipoprotein Verifier Kit 9570

  Class II

  FDA 510(k) K924904 Active Cleared 13 Jan 1993 GUDID on market

• Enzymer Verifier Kit 9430

  Class I

  FDA 510(k) K880266 Active Cleared 18 Feb 1988 GUDID on market

• Total Protein/Albumin Standard Kit, Level F 9466

  Class II

  FDA 510(k) K882116 Active Cleared 24 Jun 1988 GUDID on market

• HDL Cholesterol Verifier Kit 9560

  Class II

  FDA 510(k) K924904 Active Cleared 13 Jan 1993 GUDID on market

See all devices from Verichem Laboratories, Inc. →