COAG-I PT TEST CARD— 510(k) K882456

Name: FDA 510(k) clearance K882456
Creator: U.S. Food and Drug Administration
Published: 1988-08-25

Substantially Equivalent

Cardiovascular Diagnostic Services

FDA 510(k) clearance K882456 for COAG-I PT TEST CARD, Substantially Equivalent on 1988-08-25. Applicant: Cardiovascular Diagnostic Services. Device class: 2.

Clearance details

Applicant: Cardiovascular Diagnostic Services
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1988-06-14
Decision date: 1988-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

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K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System2023-07-14

More clearances from Cardiovascular Diagnostic Services

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K955843 — TAS PTONE1996-03-18
K933092 — TAS ANALYZER1993-11-15
K904325 — COAG-1 PT-NC TEST CARD1991-01-25
K903019 — MODIFIED COAG-1 PT TEST CARD1990-08-01
K891015 — COAG-1 APTT TEST CARD1989-05-22

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.