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)

IMMUNODOT AUTOIMMUNE SCREENING PANEL 1

K-Number: K896347 · 1989-12-05

ApplicantGeneral Biometrics, Inc.
Decision Date1989-12-05
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is General Biometrics, Inc.. It received FDA 510(k) clearance on 1989-12-05 under 510(k) number K896347. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNODOT AUTOIMMUNE SCREENING PANEL 1?

IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 is a medical device that received FDA 510(k) clearance on 1989-12-05. The listed applicant is General Biometrics, Inc.. The 510(k) number is K896347.

When did IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 receive FDA 510(k) clearance?

IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 received FDA 510(k) clearance on 1989-12-05, under 510(k) number K896347.

Who is the listed applicant for IMMUNODOT AUTOIMMUNE SCREENING PANEL 1?

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

What is the FDA product code for IMMUNODOT AUTOIMMUNE SCREENING PANEL 1?

The FDA product code for IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 is LJM.

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 General Biometrics, 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.

K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELK920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTK920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTK911627IMMUNODOT BORRELIA (LYME) TESTK911599IMMUNOWELL LYME (P39 RECOMBINANT) TESTK911590IMMUNOWELL BORRELIA (LYME)TEST

View all 23 devices →

Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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.

↑