ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES— 510(k) K880962

Name: FDA 510(k) clearance K880962
Creator: U.S. Food and Drug Administration
Published: 1988-03-30

Substantially Equivalent

Alpha-Tec Systems, Inc.

FDA 510(k) clearance K880962 for ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES, Substantially Equivalent on 1988-03-30. Applicant: Alpha-Tec Systems, Inc.. Device class: 1.

Clearance details

Applicant: Alpha-Tec Systems, Inc.
Product code: Code LJG
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-03-08
Decision date: 1988-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJG

view all

K943228 — MICROSPORIDIUM CONTROL SET1994-10-27
K924893 — MICROSPORIDIUM CONTROL SLIDE1993-01-15
K890670 — CRYPTOSPORIDIUM CONTROL SLIDE1989-03-16
K890718 — GRAM STAIN CONTROL SLIDE1989-03-16
K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE1989-02-17

More clearances from Alpha-Tec Systems, Inc.

view all

K053257 — PARA-PRO FC502006-05-12
K890861 — ATS DOBELL & O'CONNOR'S IODINE1989-03-23
K890020 — ATS LUGOL'S IODINE SOLUTION1989-02-24
K890148 — ATS TB RAPID STAIN SET PRODUCT #034-451989-01-24
K890022 — ATS MAYER'S ALBUMIN1989-01-10

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