ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)— 510(k) K160276

Name: FDA 510(k) clearance K160276
Creator: U.S. Food and Drug Administration
Published: 2016-03-03

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K160276 for ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS), Substantially Equivalent on 2016-03-03. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GKP
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 2016-02-02
Decision date: 2016-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K160276

K-number listed on FDA's recall record

Z-1014-2022 — ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097Class II·Ongoing·Instrumentation Laboratory·20220222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160276.

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