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)

SYN ENA SCREEN (PIN PLATE)

K-Number: K940229 · 1994-05-11

ApplicantElias U.S.A., Inc.
Decision Date1994-05-11
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYN ENA SCREEN (PIN PLATE) is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1994-05-11 under 510(k) number K940229. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYN ENA SCREEN (PIN PLATE)?

SYN ENA SCREEN (PIN PLATE) is a medical device that received FDA 510(k) clearance on 1994-05-11. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K940229.

When did SYN ENA SCREEN (PIN PLATE) receive FDA 510(k) clearance?

SYN ENA SCREEN (PIN PLATE) received FDA 510(k) clearance on 1994-05-11, under 510(k) number K940229.

Who is the listed applicant for SYN ENA SCREEN (PIN PLATE)?

The FDA 510(k) record lists Elias U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYN ENA SCREEN (PIN PLATE)?

The FDA product code for SYN ENA SCREEN (PIN PLATE) is LLL.

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 Elias U.S.A., 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

View all 54 devices →

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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.

↑