MMB CALIBRATOR— 510(k) K970336

Substantially Equivalent

Dade Chemistry Systems, Inc.

FDA 510(k) clearance K970336 for MMB CALIBRATOR, Substantially Equivalent on 1997-03-03. Applicant: Dade Chemistry Systems, Inc.. Device class: 2.

Clearance details

Applicant: Dade Chemistry Systems, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1997-01-29
Decision date: 1997-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIT

K171168 — VITROS Immunodiagnostic Products Insulin Calibrators2017-05-16
K170938 — CalSet IGF-12017-04-26
K170160 — Abbott ARCHITECT Free T32017-02-15
K163534 — Lumipulse G FSH-N Calibrators2017-01-13
K163546 — Lumipulse G Progesterone-N Calibrators2017-01-13

More clearances from Dade Chemistry Systems, Inc.

K973650 — TROPONIN (TROP) METHOD1997-10-20
K973099 — PROSTATE SPECIFIC ANTIGEN CONTROL1997-09-29
K973100 — PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR1997-09-29
K973101 — PROSTATE SPECIFIC ANTIGEN METHOD1997-09-18
K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM1997-04-28

Recalls naming K970336

K-number listed on FDA's recall record

Z-1925-2013 — Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20130605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970336.

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