CYANMETHEMOGLOBIN STANDARD— 510(k) K871283

Name: FDA 510(k) clearance K871283
Creator: U.S. Food and Drug Administration
Published: 1987-04-15

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K871283 for CYANMETHEMOGLOBIN STANDARD, Substantially Equivalent on 1987-04-15. Applicant: U. S. Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1987-03-31
Decision date: 1987-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRZ

view all

K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C2005-08-26
K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL)2004-06-10
K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS1996-12-18
K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS1995-07-24
K902892 — CELL-DYN CALIBRATOR1990-09-10

More clearances from U. S. Diagnostics, Inc.

view all

K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM2011-09-21
K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A2009-02-20
K061431 — EASYGLUCO, MODEL IGM-0002 G22007-01-12
K051651 — G4, MODEL IGM-00042006-04-14
K870596 — PROTHROMBIN TIME TEST1987-04-20

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