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)

AUTOZYME

K-Number: K922241 · 1992-11-30

ApplicantCambridge Life Sciences Plc.
Decision Date1992-11-30
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOZYME is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Life Sciences Plc.. It received FDA 510(k) clearance on 1992-11-30 under 510(k) number K922241. 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 AUTOZYME?

AUTOZYME is a medical device that received FDA 510(k) clearance on 1992-11-30. The listed applicant is Cambridge Life Sciences Plc.. The 510(k) number is K922241.

When did AUTOZYME receive FDA 510(k) clearance?

AUTOZYME received FDA 510(k) clearance on 1992-11-30, under 510(k) number K922241.

Who is the listed applicant for AUTOZYME?

The FDA 510(k) record lists Cambridge Life Sciences Plc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOZYME?

The FDA product code for AUTOZYME 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 Cambridge Life Sciences Plc. 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.

K940700AUTOZYME SCREENK940585SELISA ANTI-N DNA ANTIBODIESK891869CLS 962 MICROPLATE PHOTOMETER

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.

↑