510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813523Substantially Equivalent

Electric Self Sterilization Inocul. Loop

Techhnilab Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813523 is the FDA 510(k) clearance record for ELECTRIC SELF STERILIZATION INOCUL. LOOP, a class II device, cleared for Techhnilab Instruments, Inc. on under FDA product code LTB (Cyclosporine Radioimmunoassay). FDA records list 6 510(k) clearances for Techhnilab Instruments, Inc., from to . As of , FDA records show no recalls naming K813523.

Clearance record

Decision date
Received
(15 days to decision)
Product code
LTB Cyclosporine Radioimmunoassay
Regulation
21 CFR 862.1235
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Techhnilab Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LTB

Trailing 12 months

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

FDA records show no clearances under product code LTB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LTB, 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