ASO-CHECK— 510(k) K831464

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K831464 for ASO-CHECK, Substantially Equivalent on 1983-06-16. Applicant: Diagnostic Technology, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1983-05-06
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTQ

K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 68018732005-12-14
K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT1995-10-20
K915742 — TURBIQUANT ASL1993-06-28
K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT1993-06-15
K924247 — ACCUTEX ASO LATEX TEST1992-12-07

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.