HEMO FEC— 510(k) K780214

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K780214 for HEMO FEC, Substantially Equivalent on 1978-05-03. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1978-02-08
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Boehringer Mannheim Corp.

K984326 — ELECYS IGE ASSAY1999-02-08
K983047 — ACCU-CHEK HQ SYSTEM1999-02-05
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.