Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANA MICROZYME TEST SYS #1610

K-Number: K832675 · 1983-09-12

ApplicantClinical Sciences, Inc.
Decision Date1983-09-12
Product CodeDAA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA MICROZYME TEST SYS #1610 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832675. The device is classified under product code DAA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA MICROZYME TEST SYS #1610?

ANA MICROZYME TEST SYS #1610 is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K832675.

When did ANA MICROZYME TEST SYS #1610 receive FDA 510(k) clearance?

ANA MICROZYME TEST SYS #1610 received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832675.

Who is the listed applicant for ANA MICROZYME TEST SYS #1610?

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

What is the FDA product code for ANA MICROZYME TEST SYS #1610?

The FDA product code for ANA MICROZYME TEST SYS #1610 is DAA.

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 Clinical Sciences, 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.

K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITK883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590K883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550

View all 30 devices →

Related Devices (Code: DAA)

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.

K831927ANTINUCLEAR ANTIBODY TEST KITBreit Laboratories, Inc.K830005IP SPECIFIC GDiagnostic Reagent Tech.K822911ANAZYME ANA PEROXIDASE TEST SYSTEMClinical Sciences, Inc.K791749INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROLClinical Sciences, 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.

↑