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)

ELISA-DOXA SSB

K-Number: K924946 · 1993-05-19

ApplicantAdvanced Biological Products, Inc.
Decision Date1993-05-19
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELISA-DOXA SSB is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biological Products, Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K924946. 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 ELISA-DOXA SSB?

ELISA-DOXA SSB is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Advanced Biological Products, Inc.. The 510(k) number is K924946.

When did ELISA-DOXA SSB receive FDA 510(k) clearance?

ELISA-DOXA SSB received FDA 510(k) clearance on 1993-05-19, under 510(k) number K924946.

Who is the listed applicant for ELISA-DOXA SSB?

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

What is the FDA product code for ELISA-DOXA SSB?

The FDA product code for ELISA-DOXA SSB 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 Advanced Biological Products, 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.

K924945ELISA-DPXA SSA KITK924952ELISA-DOXA COMBI-6K924949ELISA-DOXA SCL-70K924948ELISA-DOXA SM/RNPK924947ELISA-DOXA SMK924951ELISA-DOXA COMBI-4

View all 8 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.

↑