Acp

FDA 510(k) K991010 · Abbott Diagnostics Mfg., Inc.

Substantially Equivalent

510(k) numberK991010

Submission

Device name
Acp
Applicant
Abbott Diagnostics Mfg., Inc.
Irving, TX, US
Received
March 26, 1999
Decision date
May 19, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CKB – Acid Phosphatase, Naphthyl Phosphate
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1020
Specialty
Clinical Chemistry

Other 510(k)s with product code CKB

510(k)DeviceApplicantDecision
K053612Dri-Stat Acid Phosphatase ReagentCKB · Traditional Beckman Coulter, Inc.04/26/2006SE
K023840Acid Phosphatase Assay for the Advia 1650CKB · Traditional Bayer Diagnostics Corp.01/07/2003SE
K981743Olympus AU400 Clinical Chemistry AnalyzerCKB · Special Olympus America, Inc.06/09/1998SE
K974695Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with…CKB · Traditional Roche Diagnostic Systems, Inc.05/21/1998SE
K963640Olympus Acid Phosphatase ReagentCKB · Traditional Olympus America, Inc.02/18/1997SE
K943366Il Test Acid PhosphataseCKB · Traditional Instrumentation Laboratory CO01/29/1996SE
K902543Acid Phosphotase Reagent Test and KitCKB · Traditional Crestat Diagnostics, Inc.09/07/1990SE
K902495Acid Phosphatase Reagent SetCKB · Traditional Tech Intl. Co.07/16/1990SE
K892393Acid Phosphatase ReagentCKB · Traditional Medical Analysis Systems, Inc.07/20/1989SE
K884747Technicon Chem 1 System Acid Phosphatase (Total)CKB · Traditional Technicon Instruments Corp.01/30/1989SE

Questions and answers

When was Acp cleared by the FDA?

Acp (K991010) received a 510(k) decision of Substantially Equivalent on May 19, 1999, 54 days after the submission was received.

What is the product code of K991010?

The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.