SPECI-MIX— 510(k) K771617

Substantially Equivalent

Thermolyne Corp.

FDA 510(k) clearance K771617 for SPECI-MIX, Substantially Equivalent on 1977-09-02. Applicant: Thermolyne Corp.. Device class: 1.

Clearance details

Applicant: Thermolyne Corp.
Product code: Code GLE
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1977-08-24
Decision date: 1977-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GLE

K823124 — IMS HEMATOLOGY MIXER1982-11-22
K800003 — CORTEX DOUBLE HELIX SAMPLER1980-02-01
K780544 — DISC-PAK ROTATOR1978-04-24
K770830 — PLATELET AGITATOR1977-07-11

More clearances from Thermolyne Corp.

K792095 — HISTO-CENTER II1979-11-20
K770914 — INCUBATOR, PORTABLE, ACT-STAT1977-08-04
K760928 — BLOOD BANK DRI-BATH1977-01-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.