FDA 510(k)

CAPTIA(R) SYPHILIS-G

K-Number: K881425 · 1988-08-04

Decision Date1988-08-04

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CAPTIA(R) SYPHILIS-G is the device name listed in this FDA 510(k) record. The listed applicant is Mercia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K881425. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPTIA(R) SYPHILIS-G?

CAPTIA(R) SYPHILIS-G is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Mercia Diagnostics , Ltd.. The 510(k) number is K881425.

When did CAPTIA(R) SYPHILIS-G receive FDA 510(k) clearance?

CAPTIA(R) SYPHILIS-G received FDA 510(k) clearance on 1988-08-04, under 510(k) number K881425.

Who is the listed applicant for CAPTIA(R) SYPHILIS-G?

The FDA 510(k) record lists Mercia Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPTIA(R) SYPHILIS-G?

The FDA product code for CAPTIA(R) SYPHILIS-G is LIP.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mercia Diagnostics , Ltd. as applicant

K915479CAPTIA CMV-TA K904524CAPTIA(R) SYPHILIS M, MODIFICATION K900654MODIFIED CAPTIA(R) SYPHILIS-M K896295CAPTIA(R) CMV-M K900655MODIFIED CAPTIA(R) TOXO-M K896194CAPTIA(R) CMV-G

View all 17 devices →

Related Devices (Code: LIP)

K241427Access SyphilisBeckman Coulter, Inc.K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics K211302Elecsys SyphilisRoche Diagnostics K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories K160910Elecsys SyphilisRoche Diagnostics K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,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.