HCT CENTRIFUGE— 510(k) K822445

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K822445 for HCT CENTRIFUGE, Substantially Equivalent on 1982-09-14. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code GKG
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1982-08-16
Decision date: 1982-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKG

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K955795 — MULTI-CENTRIFUGE1996-03-29
K930415 — MICROHEMATOCRIT ROTOR1993-03-23
K925863 — SPUNCRIT1993-02-05
K920207 — HERMLE Z230H1992-06-09

More clearances from Boehringer Mannheim Corp.

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K984419 — ELECSYS IGE CALCHECK1999-02-02
K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR1999-01-20
K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

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