CLEARENE, CLEARING AGENT— 510(k) K855109

Name: FDA 510(k) clearance K855109
Creator: U.S. Food and Drug Administration
Published: 1986-01-07

Substantially Equivalent

Surgipath Medical Industries, Inc.

FDA 510(k) clearance K855109 for CLEARENE, CLEARING AGENT, Substantially Equivalent on 1986-01-07. Applicant: Surgipath Medical Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgipath Medical Industries, Inc.
Product code: Code KEM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1985-12-23
Decision date: 1986-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayslake, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KEM

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K881282 — XYLENE1988-04-05
K874461 — HEMO-SOL1987-12-04
K861490 — PERMACLEAR SOLUTION CAT. NO. 49501986-05-06
K853694 — XYLENE SUBSTITUTE1985-10-22
K854083 — XYLENE SUBSTITUTE MONTANT1985-10-22

More clearances from Surgipath Medical Industries, Inc.

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K883217 — SCHIFF REAGENT1988-08-05
K881921 — C-E BRUSH1988-07-19
K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE1988-05-25
K881659 — TISSUE SECTION ADHESIVE1988-04-21
K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET1986-09-30

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