IMMUNO/ASO— 510(k) K894780

Substantially Equivalent

Immunostics Co., Inc.

FDA 510(k) clearance K894780 for IMMUNO/ASO, Substantially Equivalent on 1989-10-16. Applicant: Immunostics Co., Inc.. Device class: 1.

Clearance details

Applicant: Immunostics Co., Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1989-07-27
Decision date: 1989-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocean, NJ, 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 Immunostics Co., Inc.

K926569 — IMMUNO RA UNDILUTED1993-04-06
K902360 — HEMA-SCREEN1990-07-27
K883685 — IMMUNO/FEBRILE ANTIGENS1988-09-28
K872910 — IMMUNO/SLE1987-08-12
K863741 — IMMUNO-CEPT D (BETA-MONOCLONAL)1986-11-13

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