510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770508Substantially Equivalent

Smac System

Mid Tech, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770508 is the FDA 510(k) clearance record for SMAC SYSTEM, a class I device, cleared for Mid Tech, Inc. on under FDA product code JCC (Ph Buffer). FDA records list 5 510(k) clearances for Mid Tech, Inc., from to . As of , FDA records show no recalls naming K770508.

Clearance record

Decision date
Received
(53 days to decision)
Product code
JCC Ph Buffer
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Mid Tech, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JCC

Trailing 12 months

FDA records hold no clearances under product code JCC in the trailing twelve months.

FDA records show no clearances under product code JCC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JCC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260