Hemopexin Nephelometric Assays

FDA 510(k) K780250 · Kallestad Laboratories, Inc.

Substantially Equivalent

510(k) numberK780250

Submission

Device name
Hemopexin Nephelometric Assays
Applicant
Kallestad Laboratories, Inc.
Mchenry, IL, US
Received
February 14, 1978
Decision date
February 28, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CZX – Hemopexin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5490
Specialty
Immunology

Other 510(k)s with product code CZX

510(k)DeviceApplicantDecision
K801432Hemopexin Nephelometric AssayCZX · Traditional J.T. Baker Chemical Co.07/08/1980SE
K790713Antiserum to Human HemopexinCZX · Traditional Kent Laboratories, Inc.09/04/1979SE

More from Kent Laboratories, Inc.

510(k)DeviceDecision
K863681Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional 12/03/1986SE
K862917Pathfinder Rotavirus ChemiluminescentLIQ · Traditional 10/22/1986SE
K863682Pathfinder(Tm) Specimen Collection KitJSM · Traditional 10/10/1986SE
K862743Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional 09/29/1986SE
K862313Kallestad Sm/Rnp Test ReagentLKJ · Traditional 08/06/1986SE
K862710Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional 07/29/1986SE
K855014Quantimetric Plus Calibrator/Control Set aJIX · Traditional 03/14/1986SE
K855010Quantimetric Plus Igm Reagent KitDFT · Traditional 02/28/1986SE
K855013Quantimetric Plus Support PackDEH · Traditional 02/26/1986SE
K855012Quantimetric Plus C4 Reagent KitDBI · Traditional 02/26/1986SE

Questions and answers

When was Hemopexin Nephelometric Assays cleared by the FDA?

Hemopexin Nephelometric Assays (K780250) received a 510(k) decision of Substantially Equivalent on February 28, 1978, 14 days after the submission was received.

What is the product code of K780250?

The FDA product code is CZX – Hemopexin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5490.