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FDA 510(k)

ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS

K-Number: K881367 · 1988-06-27

ApplicantInstrumentation Laboratory CO
Decision Date1988-06-27
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1988-06-27 under 510(k) number K881367. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS?

ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS is a medical device that received FDA 510(k) clearance on 1988-06-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K881367.

When did ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS receive FDA 510(k) clearance?

ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS received FDA 510(k) clearance on 1988-06-27, under 510(k) number K881367.

Who is the listed applicant for ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS?

The FDA product code for ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS is JPA.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Instrumentation Laboratory CO as applicant

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Related Devices (Code: JPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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