HEMOPLUS— 510(k) K913622

Substantially Equivalent

Sarstedt, Inc.

FDA 510(k) clearance K913622 for HEMOPLUS, Substantially Equivalent on 1992-01-31. Applicant: Sarstedt, Inc.. Device class: 2.

Clearance details

Applicant: Sarstedt, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1991-08-14
Decision date: 1992-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sarstedt, Inc.

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K024237 — URINE MONOVETTE BORIC ACID2003-04-14
K003382 — SARSTEDT NEEDLE PROTECTOR2001-03-30

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