Alkphor System

Q: When was Alkphor System cleared by the FDA?

Alkphor System (K823445) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 42 days after the submission was received.

Q: What is the product code of K823445?

The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.

FDA 510(k) K823445 · California Immuno Diagnostic, Inc.

Substantially Equivalent

510(k) numberK823445

Submission

Device name: Alkphor System
Applicant: California Immuno Diagnostic, Inc.
Mchenry, IL, US
Received: November 16, 1982
Decision date: December 28, 1982
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1050
Specialty: Clinical Chemistry

Other 510(k)s with product code CIN

510(k)	Device	Applicant	Decision
K232904	Access OstaseCIN · Traditional	Beckman Coulter	04/15/2024SE
K200475	IDS-iSYS Ostase BAPCIN · Traditional	Immunodiagnostic Systems , Ltd.	09/30/2020SE
K043125	Orion Diagnostica Uniq Pinp RiaCIN · Traditional	Orion Diagnostica, OY	05/04/2005SE
K020625	Spife 2000/3000 Alp 40, 20; Models 3345 and 3346CIN · Traditional	Helena Laboratories	05/06/2002SE
K011113	Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN…CIN · Traditional	Sebia	06/13/2001SE
K994278	Access Ostase Immunoenzymetric AssayCIN · Traditional	Beckman Coulter, Inc.	03/28/2000SE
K981373	Alkphase-B Assay KitCIN · Traditional	Metra Biosystems, Inc.	05/27/1998SE
K972666	Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional	Hybritech, Inc.	09/11/1997SE
K964764	Opus Bone AlpCIN · Traditional	Behring Diagnostics, Inc.	01/24/1997SE
K961573	Tandem-R Ostase Immunoradiometric AssayCIN · Traditional	Hybritech, Inc.	08/19/1996SE

More from Hybritech, Inc.

510(k)	Device	Decision
K831623	Dia Strips SystemCDM · Traditional	07/28/1983SE
K800698	Autofluor SystemJZT · Traditional	05/28/1980SE

Questions and answers

When was Alkphor System cleared by the FDA?

Alkphor System (K823445) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 42 days after the submission was received.

What is the product code of K823445?

The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.