Immage Immunochemistry System Prealbumin (Pab) Reagent

FDA 510(k) K964781 · Beckman Instruments, Inc.

Substantially Equivalent

510(k) numberK964781

Submission

Device name
Immage Immunochemistry System Prealbumin (Pab) Reagent
Applicant
Beckman Instruments, Inc.
Brea, CA, US
Received
November 27, 1996
Decision date
May 9, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DDS – Prealbumin, Fitc, Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5060
Specialty
Immunology

Other 510(k)s with product code DDS

510(k)DeviceApplicantDecision
K972812Raichem Prealbumin SpiaDDS · Traditional Hemagen Diagnostics, Inc.08/28/1997SE
K934966SPQ Pal Control Level IIDDS · Traditional Incstar Corp.01/11/1994SE
K854811Ics Pab Prealbumin Reagent Test KitDDS · Traditional Beckman Instruments, Inc.01/24/1986SE

More from Beckman Instruments, Inc.

510(k)DeviceDecision
K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional 09/17/1998SE
K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional 07/14/1998SE
K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional 05/08/1998SE
K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional 05/01/1998SE
K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional 03/18/1998SE
K974816Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional 02/20/1998SE
K974564Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional 02/17/1998SE
K974110Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional 12/24/1997SE
K974452Vigil Lipid ControlJJY · Traditional 12/17/1997SE
K973932Beckman Calibrator 2 (CAL2)JIX · Traditional 12/15/1997SE

Questions and answers

When was Immage Immunochemistry System Prealbumin (Pab) Reagent cleared by the FDA?

Immage Immunochemistry System Prealbumin (Pab) Reagent (K964781) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 163 days after the submission was received.

What is the product code of K964781?

The FDA product code is DDS – Prealbumin, Fitc, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.