ULTRACLONE 05-100 GUINEA PIG RBC— 510(k) K854206

Name: FDA 510(k) clearance K854206
Creator: U.S. Food and Drug Administration
Published: 1985-10-31

Substantially Equivalent

Earl-Clay Laboratories, Inc.

FDA 510(k) clearance K854206 for ULTRACLONE 05-100 GUINEA PIG RBC, Substantially Equivalent on 1985-10-31. Applicant: Earl-Clay Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Earl-Clay Laboratories, Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-16
Decision date: 1985-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Novato, CA, US

Download summary PDF View on FDA.gov ↗

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K861585 — ULTRACLONE 01-2300 CELL LINE1986-05-13
K861569 — ULTRACLONE 01-700 CELL LINE1986-05-05
K853203 — ULTRACLONE ECL-01-2200 CELL LINE1985-08-12
K851545 — ULTRACLONE ECL-01-800 CELL LINE1985-05-10
K843577 — ULTRAXLONE ECL-01-1000 CELL LINE1984-10-31

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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