Alk-Phos Biopak Gel

Q: What is the product code of K810144?

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) K810144 · Bioware Products

Substantially Equivalent

510(k) numberK810144

Submission

Device name: Alk-Phos Biopak Gel
Applicant: Bioware Products
Mchenry, IL, US
Received: January 21, 1981
Decision date: February 2, 1981
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

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More from Hybritech, Inc.

510(k)	Device	Decision
K802299	K/K (Asma/Ana) Universal BiopakDHN · Traditional	01/29/1981SE
K802308	T/K (Ata/Ama) Universal BiopakDBM · Traditional	12/01/1980SE
K802276	Fta-Abs BiopakJWL · Traditional	10/23/1980SE

Questions and answers

When was Alk-Phos Biopak Gel cleared by the FDA?

Alk-Phos Biopak Gel (K810144) received a 510(k) decision of Substantially Equivalent on February 2, 1981, 12 days after the submission was received.

What is the product code of K810144?

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