KIT, METHADONE (TOXI-PAK IMMUNO HI)— 510(k) K760075

Name: FDA 510(k) clearance K760075
Creator: U.S. Food and Drug Administration
Published: 1976-07-20

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K760075 for KIT, METHADONE (TOXI-PAK IMMUNO HI), Substantially Equivalent on 1976-07-20. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code DIW
Device class: Class 2
Regulation: 21 CFR 862.3620
Advisory panel: Clinical Toxicology
Date received: 1976-06-18
Decision date: 1976-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIW

view all

K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE1995-03-21
K930845 — ROCHE ABUSCREEN ONTRAK FOR METHADONE1993-04-20
K801509 — HI-M-TEST FOR METHADONE TEST #21980-07-14

More clearances from J.T. Baker Chemical Co.

view all

K803128 — SERIES 810 PLATELET ANALYZER1981-04-03
K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT1980-10-10
K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC1980-09-26
K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT1980-09-26
K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC1980-09-16

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