Smac System

FDA 510(k) K770508 · Mid Tech, Inc.

Substantially Equivalent

510(k) numberK770508

Submission

Device name
Smac System
Applicant
Mid Tech, Inc.
Mchenry, IL, US
Received
March 17, 1977
Decision date
May 9, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JCC – Ph Buffer
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code JCC

510(k)DeviceApplicantDecision
K842918Scotts Tap Water SubstituteJCC · Traditional E K Ind., Inc.09/11/1984SE
K842914Wright Stain BufferJCC · Traditional E K Ind., Inc.09/07/1984SE
K841423Scotts Tap Water Substitute 7JCC · Traditional Reagent Laboratory, Inc.05/22/1984SE
K811791Phosphate Buffered Saline (1X)JCC · Traditional Dutchland Laboratories, Inc.08/25/1981SE
K811251Citrate BufferJCC · Traditional Bioscientific05/21/1981SE
K792574Mopso BufferJCC · Traditional Electrophoresis Corp. of America01/21/1980SE

More from Electrophoresis Corp. of America

510(k)DeviceDecision
K810951Reagents for Quant. Enzymatic Deter.-Tr. · Traditional 04/23/1981SE
K791869Glucose Oxidase (Frinder) KitCGA · Traditional 10/01/1979SE
K791313Ars, ChemistryJJY · Traditional 08/16/1979SE
K771033Smac Sys., Supplemental Products forCKA · Traditional 08/04/1977SE

Questions and answers

When was Smac System cleared by the FDA?

Smac System (K770508) received a 510(k) decision of Substantially Equivalent on May 9, 1977, 53 days after the submission was received.

What is the product code of K770508?

The FDA product code is JCC – Ph Buffer, a Class I (low risk) device regulated under 21 CFR 864.4010.