PARA 5 DIFF— 510(k) K935196

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K935196 for PARA 5 DIFF, Substantially Equivalent on 1994-04-05. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1993-10-26
Decision date: 1994-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omaha, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

K160586 — XN-L CHECK2016-12-22
K160588 — XN CHECK BF2016-12-22
K160590 — XN CHECK2016-12-22
K160606 — BC-5D Hematology Control2016-09-01
K141957 — XN CHECK BF2014-12-05

More clearances from Streck Laboratories, Inc.

K042587 — RETIC-CHEX FOR CELL-DYN2004-10-19
K040107 — CYTO-CHEX BCT2004-07-27
K040025 — A1C-CELLULAR2004-03-02
K023656 — SICKLE-CHEX SOLUBILITY KIT2002-12-30
K021922 — MODIFICATION TO PARA 5X2002-06-25

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