REFLOTRON HEMOGLOBIN TEST TABS— 510(k) K934064

Name: FDA 510(k) clearance K934064
Creator: U.S. Food and Drug Administration
Published: 1993-12-06

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K934064 for REFLOTRON HEMOGLOBIN TEST TABS, Substantially Equivalent on 1993-12-06. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1993-06-30
Decision date: 1993-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHG

view all

K221508 — AnemoCheck Home2023-09-29
K163215 — AnemoCheck2017-09-13
K042379 — ANEMIAPRO SELF-SCREENER2004-12-15
K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 900902002-02-11
K001462 — CARESIDE HEMOGLOBIN2000-08-21

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.