COUNT-A-PART PLUS— 510(k) K841809

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K841809 for COUNT-A-PART PLUS, Substantially Equivalent on 1984-11-30. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-05-01
Decision date: 1984-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, 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 Diagnostic Technology, Inc.

K896378 — LYME-CHECK(TM) TEST KIT1991-11-05
K903612 — EBV/EA-CHECK TM TEST KIT1990-10-16
K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT1989-06-20
K890819 — HSV-CHECK(TM) TEST KIT1989-06-20
K891542 — EBNA-CHECK(TM) TEST KIT1989-06-20

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