510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780962Substantially Equivalent

Automated Enzyme

Hyland Therapeutic Div., Travenol Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780962 is the FDA 510(k) clearance record for AUTOMATED ENZYME, a class II device, cleared for Hyland Therapeutic Div., Travenol Laboratories on under FDA product code KSK (Solution, Stabilized Enzyme). FDA records list 44 510(k) clearances for Hyland Therapeutic Div., Travenol Laboratories, from to . As of , FDA records show no recalls naming K780962.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KSK Solution, Stabilized Enzyme
Regulation
21 CFR 864.9400
Device class
Class II
Review panel
Hematology
Applicant
Hyland Therapeutic Div., Travenol Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSK

Trailing 12 months

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

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