FLEET DETECTATEST— 510(k) K812728

Substantially Equivalent

C.B. Fleet Co., Inc.

FDA 510(k) clearance K812728 for FLEET DETECTATEST, Substantially Equivalent on 1982-07-02. Applicant: C.B. Fleet Co., Inc.. Device class: 2.

Clearance details

Applicant: C.B. Fleet Co., Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1981-09-28
Decision date: 1982-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHE

K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test2018-02-15
K170548 — InSure ONE2017-10-05
K171484 — hema-screen SPECIFIC Gold2017-06-14
K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test2017-05-14
K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2017-01-17

More clearances from C.B. Fleet Co., Inc.

K990597 — SUMMER'S EVE LUBRICATING JELLY1999-07-19

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