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FDA 510(k)

ORTHO *APO A-1 ELISA TEST SYSTEM

K-Number: K895160 · 1989-10-06

ApplicantMedical Marketing Consultants, Inc.
Decision Date1989-10-06
Product CodeDEL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORTHO *APO A-1 ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Marketing Consultants, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895160. The device is classified under product code DEL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO *APO A-1 ELISA TEST SYSTEM?

ORTHO *APO A-1 ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Medical Marketing Consultants, Inc.. The 510(k) number is K895160.

When did ORTHO *APO A-1 ELISA TEST SYSTEM receive FDA 510(k) clearance?

ORTHO *APO A-1 ELISA TEST SYSTEM received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895160.

Who is the listed applicant for ORTHO *APO A-1 ELISA TEST SYSTEM?

The FDA 510(k) record lists Medical Marketing Consultants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO *APO A-1 ELISA TEST SYSTEM?

The FDA product code for ORTHO *APO A-1 ELISA TEST SYSTEM is DEL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Marketing Consultants, Inc. 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.

K895277ORTHO APO B ELISA TEST SYSTEM

Related Devices (Code: DEL)

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.

K013278TINA-QUANT APOLIPOPROTEIN A-1 VER.2Roche Diagnostics Corp.K901675APOLIPOPROTEIN A-I (APO A-I)Sigma Chemical Co.K900124APOLIPOPROTEIN B (APO B)Sigma Chemical Co.K893885BACTON TM, BASIC TM, APO A-I REAGENTCatachem, 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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