Cleared Traditional

MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85

K884436 · Harris Mfg. Co. · Chemistry
Dec 1988
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K884436 is an FDA 510(k) clearance for the MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85, a Refrigerator, Freezer, Blood Storage (Class II — Special Controls, product code KSE), submitted by Harris Mfg. Co. (Trenton, US). The FDA issued a Cleared decision on December 2, 1988, 42 days after receiving the submission on October 21, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.9700.

Submission Details

510(k) Number K884436 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1988
Decision Date December 02, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KSE — Refrigerator, Freezer, Blood Storage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.9700