PHOLPHORYL-ASE TUBES— 510(k) K811853

Name: FDA 510(k) clearance K811853
Creator: U.S. Food and Drug Administration
Published: 1981-07-16

Substantially Equivalent

Microchemical Specialities, Co.

FDA 510(k) clearance K811853 for PHOLPHORYL-ASE TUBES, Substantially Equivalent on 1981-07-16. Applicant: Microchemical Specialities, Co.. Device class: 1.

Clearance details

Applicant: Microchemical Specialities, Co.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1981-07-01
Decision date: 1981-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTO

view all

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

More clearances from Microchemical Specialities, Co.

view all

K823198 — RAPID PRESUMPTIVE IDENT. GPA STREP1982-11-16
K821992 — ALPHA-TOXIN DISCS1982-10-18
K811852 — REDUCT-ASE TUBES1981-07-16
K811854 — GALACTOSID-ASE TUBES1981-07-16
K801915 — ENZYME-ASE I TUBES1980-08-20

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