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)

ACCULYTE CHEMILUMINESCENCE ANALYZER

K-Number: K921536 · 1993-10-12

ApplicantLaboratory Technologies, Inc.
Decision Date1993-10-12
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCULYTE CHEMILUMINESCENCE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Technologies, Inc.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K921536. 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 ACCULYTE CHEMILUMINESCENCE ANALYZER?

ACCULYTE CHEMILUMINESCENCE ANALYZER is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Laboratory Technologies, Inc.. The 510(k) number is K921536.

When did ACCULYTE CHEMILUMINESCENCE ANALYZER receive FDA 510(k) clearance?

ACCULYTE CHEMILUMINESCENCE ANALYZER received FDA 510(k) clearance on 1993-10-12, under 510(k) number K921536.

Who is the listed applicant for ACCULYTE CHEMILUMINESCENCE ANALYZER?

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

What is the FDA product code for ACCULYTE CHEMILUMINESCENCE ANALYZER?

The FDA product code for ACCULYTE CHEMILUMINESCENCE ANALYZER 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 Laboratory Technologies, 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.

K900087GENESYS 6000 GAMMA COUNTERK882194GEMINII GAMMA COUNTERK851689GENESYS GAMMA COUNTER

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.

↑