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)

IMMUNOWELL RNP/SM ANTIBODY TEST

K-Number: K911848 · 1991-05-07

ApplicantGeneral Biometrics, Inc.
Decision Date1991-05-07
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOWELL RNP/SM ANTIBODY TEST 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 1991-05-07 under 510(k) number K911848. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOWELL RNP/SM ANTIBODY TEST?

IMMUNOWELL RNP/SM ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is General Biometrics, Inc.. The 510(k) number is K911848.

When did IMMUNOWELL RNP/SM ANTIBODY TEST receive FDA 510(k) clearance?

IMMUNOWELL RNP/SM ANTIBODY TEST received FDA 510(k) clearance on 1991-05-07, under 510(k) number K911848.

Who is the listed applicant for IMMUNOWELL RNP/SM ANTIBODY TEST?

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 IMMUNOWELL RNP/SM ANTIBODY TEST?

The FDA product code for IMMUNOWELL RNP/SM ANTIBODY TEST is LKP.

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: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbHK024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad

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.

↑