SEPCOR TEMPERATURE MONITOR— 510(k) K813327

Name: FDA 510(k) clearance K813327
Creator: U.S. Food and Drug Administration
Published: 1981-12-31

Substantially Equivalent

Separation Science Corp.

FDA 510(k) clearance K813327 for SEPCOR TEMPERATURE MONITOR, Substantially Equivalent on 1981-12-31. Applicant: Separation Science Corp.. Device class: 2.

Clearance details

Applicant: Separation Science Corp.
Product code: Code KSE
Device class: Class 2
Regulation: 21 CFR 864.9700
Advisory panel: Hematology
Date received: 1981-11-24
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K884436 — MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-851988-12-02
K802319 — HEMOTEMP TM1980-10-10
K800667 — MONITEMP BLOOD PACK TEMP. MONITOR1980-04-16

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K820712 — SEPCOR UNIT COLLECTION MONITOR1982-05-07

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