Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873;

Q: What is the product code of K052645?

The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.

FDA 510(k) K052645 · Ortho-Clinical Diagnostics

Substantially Equivalent

510(k) numberK052645

Submission

Device name: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873;
Applicant: Ortho-Clinical Diagnostics
Rochester, NY, US
Received: September 26, 2005
Decision date: December 14, 2005
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GTQ – Antistreptolysin - Titer/Streptolysin O Reagent
Device class: Class I (low risk)
Regulation: 21 CFR 866.3720
Specialty: Microbiology

Other 510(k)s with product code GTQ

510(k)	Device	Applicant	Decision
K953437	Olympus Anti-Sterptolysin O Immunoturbidimetric ReagentGTQ · Traditional	Olympus America, Inc.	10/20/1995SE
K915742	Turbiquant AslGTQ · Traditional	Behring Diagnostics, Inc.	06/28/1993SE
K926236	Beckman Anti-Streptolysin O KitGTQ · Traditional	Beckman Instruments, Inc.	06/15/1993SE
K924247	Accutex Aso Latex TestGTQ · Traditional	J.S. Medical Assoc.	12/07/1992SE
K922723	Tech Simple Antistreptolysin O Aso Serum ControlGTQ · Traditional	Simplicity Diagnostics, Inc.	09/18/1992SE
K915053	Beckman Antistreptolysin O, ModificationGTQ · Traditional	Beckman Instruments, Inc.	03/19/1992SE
K912150	Beckman Anti-Streptolysin O (Aso) KitGTQ · Traditional	Beckman Instruments, Inc.	07/17/1991SE
K904416	Croatest (R) Rheumatoid DiagnosticGTQ · Traditional	Biotrax, Inc.	06/24/1991SE
K910887	QM300 Control G PackGTQ · Traditional	Kallestad Diag, A Div. of Erbamont, Inc.	06/17/1991SE
K910886	QM300 Antistreptolysin O (Aso) Antigen PackGTQ · Traditional	Kallestad Diag, A Div. of Erbamont, Inc.	06/17/1991SE

More from Kallestad Diag, A Div. of Erbamont, Inc.

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K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional	05/08/2024SE
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K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional	08/09/2023SE
K221355	VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional	12/12/2022SE
K213626	Vitros AfpLOJ · Traditional	06/15/2022SE
K212648	VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional	01/28/2022SE
K201312	VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional	10/04/2021SE

Questions and answers

When was Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873; cleared by the FDA?

Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873; (K052645) received a 510(k) decision of Substantially Equivalent on December 14, 2005, 79 days after the submission was received.

What is the product code of K052645?

The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.