BLOOD PH CAPILLARY TUBES, HEPARIN— 510(k) K881188

Name: FDA 510(k) clearance K881188
Creator: U.S. Food and Drug Administration
Published: 1988-07-08

Substantially Equivalent

Helps Products, Inc.

FDA 510(k) clearance K881188 for BLOOD PH CAPILLARY TUBES, HEPARIN, Substantially Equivalent on 1988-07-08. Applicant: Helps Products, Inc.. Device class: 2.

Clearance details

Applicant: Helps Products, Inc.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1988-03-21
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Helps Products, Inc.

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K881186 — MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL1988-05-13
K881187 — NATELSON TUBES, HEPARIN AND PLAIN1988-05-06
K881262 — CARAWAY TUBES, HEPARIN AND PLAIN1988-05-06

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.