DMAC INDOLE REAGENT— 510(k) K902640

Substantially Equivalent

Api Analytab Products

FDA 510(k) clearance K902640 for DMAC INDOLE REAGENT, Substantially Equivalent on 1990-07-16. Applicant: Api Analytab Products. Device class: 1.

Clearance details

Applicant: Api Analytab Products
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1990-06-14
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainveiw, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTO

K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT2005-09-01
K970832 — PYR SWAB1997-04-24
K970834 — GRAM SWAB1997-04-17
K970833 — INDOLE SWAB1997-04-02
K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN1997-02-06

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