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)

MODIFIED MODEL 535(TM) LUMINOMETER

K-Number: K896117 · 1989-11-30

ApplicantLos Alamos Diagnostics
Decision Date1989-11-30
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED MODEL 535(TM) LUMINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Los Alamos Diagnostics. It received FDA 510(k) clearance on 1989-11-30 under 510(k) number K896117. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED MODEL 535(TM) LUMINOMETER?

MODIFIED MODEL 535(TM) LUMINOMETER is a medical device that received FDA 510(k) clearance on 1989-11-30. The listed applicant is Los Alamos Diagnostics. The 510(k) number is K896117.

When did MODIFIED MODEL 535(TM) LUMINOMETER receive FDA 510(k) clearance?

MODIFIED MODEL 535(TM) LUMINOMETER received FDA 510(k) clearance on 1989-11-30, under 510(k) number K896117.

Who is the listed applicant for MODIFIED MODEL 535(TM) LUMINOMETER?

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

What is the FDA product code for MODIFIED MODEL 535(TM) LUMINOMETER?

The FDA product code for MODIFIED MODEL 535(TM) LUMINOMETER is JJQ.

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 Los Alamos Diagnostics 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.

K883385RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TESTK882608LAD MODEL 633 LUMINOMETERK881439MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEMK874262LAD MODEL 735 LUMINOMETERK864202UTISCREEN(R) BACTERIAL ATP TESTK864201LAD MODEL 535 LUMINOMETER

View all 7 devices →

Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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.

↑