BC THROMBIN REAGENT— 510(k) K970645

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K970645 for BC THROMBIN REAGENT, Substantially Equivalent on 1997-05-19. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1997-02-20
Decision date: 1997-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJA

K050817 — T-TEK2005-12-12
K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A45891998-10-15
K925493 — BIOMERIEUX HEMOLAB THROMBICALCI-TEST1994-04-21
K930157 — TEST THROMBIN1993-05-14
K923220 — THROMBIN CLOT TIME TEST PROCEDURE1992-09-29

More clearances from Behring Diagnostics, Inc.

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972316 — OPUS D-DIMER1997-09-09

Recalls naming K970645

K-number listed on FDA's recall record

Z-0827-2018 — BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.Class II·Terminated·Siemens Healthcare Diagnostics·20171017

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970645.

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