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FDA 510(k)

AUTOZYME SCREEN

K-Number: K940700 · 1994-06-10

ApplicantCambridge Life Sciences Plc.
Decision Date1994-06-10
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOZYME SCREEN 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 1994-06-10 under 510(k) number K940700. 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 AUTOZYME SCREEN?

AUTOZYME SCREEN is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Cambridge Life Sciences Plc.. The 510(k) number is K940700.

When did AUTOZYME SCREEN receive FDA 510(k) clearance?

AUTOZYME SCREEN received FDA 510(k) clearance on 1994-06-10, under 510(k) number K940700.

Who is the listed applicant for AUTOZYME SCREEN?

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 SCREEN?

The FDA product code for AUTOZYME SCREEN 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.

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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.

K940585SELISA ANTI-N DNA ANTIBODIESK922241AUTOZYMEK891869CLS 962 MICROPLATE PHOTOMETER

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

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