DADE HEPZYME— 510(k) K925452

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K925452 for DADE HEPZYME, Substantially Equivalent on 1993-01-11. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code JBR
Device class: Class 2
Regulation: 21 CFR 864.7525
Advisory panel: Hematology
Date received: 1992-10-28
Decision date: 1993-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Recent devices under product code JBR

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K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS1995-04-14
K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY1995-04-11
K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-03-07

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