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FDA 510(k)

CEA CONTROL PLASMA

K-Number: K812658 · 1981-09-29

ApplicantPacific Hemostasis
Decision Date1981-09-29
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CEA CONTROL PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812658. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEA CONTROL PLASMA?

CEA CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Pacific Hemostasis. The 510(k) number is K812658.

When did CEA CONTROL PLASMA receive FDA 510(k) clearance?

CEA CONTROL PLASMA received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812658.

Who is the listed applicant for CEA CONTROL PLASMA?

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

What is the FDA product code for CEA CONTROL PLASMA?

The FDA product code for CEA CONTROL PLASMA is DHX.

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Other records listing Pacific Hemostasis as applicant

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.

K000679THROMBOSTRATE CONTROL PLASMASK994100PACIFIC HEMOSTASIS THROMBOPLASTIN DK992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CK992279HEPARIN CONTROL PLASMA LEVEL 2K992278HEPARIN CONTROL PLASMA LEVEL 1K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

View all 29 devices →

Related Devices (Code: DHX)

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.

K223921Access CEABeckman Coulter, Inc.K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical DiagnosticsK200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc.K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENOlympus America, Inc.K080194VIDAS CEA (S) ASSAYbioMerieux, Inc.K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)Dade Behring, Inc.

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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