LDH Procedure

FDA 510(k) K781323 · Analytical & Research Chemicals, Inc.

Substantially Equivalent

510(k) numberK781323

Submission

Device name
LDH Procedure
Applicant
Analytical & Research Chemicals, Inc.
Mchenry, IL, US
Received
July 31, 1978
Decision date
August 31, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Analytical & Research Chemicals, Inc.

510(k)DeviceDecision
K823806Direct Creatinine ProcedureCGX · Traditional 01/14/1983SE
K823786Alkaline PhosphataseCJE · Traditional 01/14/1983SE
K823784Enzymatic Cholesterol (ColorimetricCHH · Traditional 01/14/1983SE
K781460Chloride ReagentCHJ · Traditional 10/10/1978SE
K781441BCG Albumin ReagetCIX · Traditional 10/10/1978SE
K781324Alp TestCIO · Traditional 08/31/1978SE
K781309Got Procedure · Traditional 08/31/1978SE
K781308GlucolourCGE · Traditional 08/31/1978SE
K781307Glucose Determ. KitCGA · Traditional 08/31/1978SE
K781306Urea Nitrogen Test KitCDL · Traditional 08/31/1978SE

Questions and answers

When was LDH Procedure cleared by the FDA?

LDH Procedure (K781323) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 31 days after the submission was received.