HEMOTEMP TM— 510(k) K802319

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K802319 for HEMOTEMP TM, Substantially Equivalent on 1980-10-10. Applicant: Marion Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code KSE
Device class: Class 2
Regulation: 21 CFR 864.9700
Advisory panel: Hematology
Date received: 1980-09-23
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KSE

K884436 — MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-851988-12-02
K813327 — SEPCOR TEMPERATURE MONITOR1981-12-31
K800667 — MONITEMP BLOOD PACK TEMP. MONITOR1980-04-16

More clearances from Marion Laboratories, Inc.

K883391 — POLYMER ADHESIVE BANDAGE1989-03-23
K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN1988-07-05
K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM1988-05-27
K874554 — ENVICLUSIVE (TM)1988-03-11
K874551 — ENVINET(TM)1988-01-22

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