Calcium/Lithium Test Beckman Synchron El-Ise Analy

FDA 510(k) K914510 · Beckman Instruments, Inc.

Substantially Equivalent

510(k) numberK914510

Submission

Device name
Calcium/Lithium Test Beckman Synchron El-Ise Analy
Applicant
Beckman Instruments, Inc.
Brea, CA, US
Received
October 9, 1991
Decision date
November 19, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JFN – Atomic Absorption, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

Other 510(k)s with product code JFN

510(k)DeviceApplicantDecision
K871903Quick Qualitative Calcium Test (Quick-Cal)JFN · Traditional Creative Scientific Technology, Inc.09/02/1987SE
K770570Calcium/Magnesium AnalyzerJFN · Traditional Beckman Instruments, Inc.06/08/1977SE

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 Calcium/Lithium Test Beckman Synchron El-Ise Analy cleared by the FDA?

Calcium/Lithium Test Beckman Synchron El-Ise Analy (K914510) received a 510(k) decision of Substantially Equivalent on November 19, 1991, 41 days after the submission was received.

What is the product code of K914510?

The FDA product code is JFN – Atomic Absorption, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.