510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884436Substantially Equivalent

Modified Low-Temp. Freezer Model Hlt-80Ls-85

Harris Mfg. Co., Trenton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884436 is the FDA 510(k) clearance record for MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85, a class II device, cleared for Harris Mfg. Co. on under FDA product code KSE (Refrigerator, Freezer, Blood Storage). FDA records list 2 510(k) clearances for Harris Mfg. Co., from to . As of , FDA records show no recalls naming K884436.

Clearance record

Decision date
Received
(42 days to decision)
Product code
KSE Refrigerator, Freezer, Blood Storage
Regulation
21 CFR 864.9700
Device class
Class II
Review panel
Hematology
Applicant
Harris Mfg. Co. P.O. Box 5878, Trenton NJ
Third party review
No

Clearances, product code KSE

Trailing 12 months

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

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