STREP-A-CHEK— 510(k) K934129

Substantially Equivalent

E-Y Laboratories, Inc.

FDA 510(k) clearance K934129 for STREP-A-CHEK, Substantially Equivalent on 1994-08-26. Applicant: E-Y Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: E-Y Laboratories, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1993-08-12
Decision date: 1994-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, 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

More clearances from E-Y Laboratories, Inc.

K934130 — SWABZYME OXIDASE1994-09-14
K934125 — GONOCHEK-II, MODIFICATION1994-09-09
K940161 — B-LACTAMASE REAGENT TUBES1994-09-09
K940162 — GONOCHEK II REAGENT TUBES1994-09-09
K940020 — STREP-A-CHEK(TM) REAGENT STRIPS1994-08-26

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