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FDA 510(k)

LONZA FORMULATION R-82

K-Number: K932502 · 1994-05-12

ApplicantLonza, Inc.
Decision Date1994-05-12
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LONZA FORMULATION R-82 is the device name listed in this FDA 510(k) record. The listed applicant is Lonza, Inc.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K932502. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONZA FORMULATION R-82?

LONZA FORMULATION R-82 is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Lonza, Inc.. The 510(k) number is K932502.

When did LONZA FORMULATION R-82 receive FDA 510(k) clearance?

LONZA FORMULATION R-82 received FDA 510(k) clearance on 1994-05-12, under 510(k) number K932502.

Who is the listed applicant for LONZA FORMULATION R-82?

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

What is the FDA product code for LONZA FORMULATION R-82?

The FDA product code for LONZA FORMULATION R-82 is LRJ. This falls under the Clinical Lab category.

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.

Related Devices (Code: LRJ)

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.

Official Source

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