FTA-ABS TEST— 510(k) K801959

Substantially Equivalent

Immuno-Diagnostic Products, Inc.

FDA 510(k) clearance K801959 for FTA-ABS TEST, Substantially Equivalent on 1980-10-23. Applicant: Immuno-Diagnostic Products, Inc.. Device class: 2.

Clearance details

Applicant: Immuno-Diagnostic Products, Inc.
Product code: Code JWL
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1980-08-19
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWL

K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILIS1983-07-26
K802276 — FTA-ABS BIOPAK1980-10-23
K801928 — LAB-TEK FTA-ABS KIT1980-08-20

More clearances from Immuno-Diagnostic Products, Inc.

K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT1986-04-24
K811021 — HERPES1981-11-05
K811562 — TOXOPLASMOSIS TEST KIT1981-07-16
K811022 — ANA TEST KIT1981-04-23
K801963 — CMV TEST KIT1980-10-23

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