UNITEST CREATINE KINASE— 510(k) K782156

Name: FDA 510(k) clearance K782156
Creator: U.S. Food and Drug Administration
Published: 1979-03-02

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K782156 for UNITEST CREATINE KINASE, Substantially Equivalent on 1979-03-02. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JLB
Device class: Class 1
Regulation: 21 CFR 862.1210
Advisory panel: Clinical Chemistry
Date received: 1978-12-22
Decision date: 1979-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JLB

view all

K992140 — PICCOLO METLYTE 7 REAGENT DISC1999-08-26
K971817 — OLYMPUS CK-MB REAGENT1997-06-11

More clearances from Boehringer Mannheim Corp.

view all

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.