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FDA 510(k)

DILULAB 230

K-Number: K823522 · 1982-12-28

ApplicantInnovative Medical Systems, Inc.
Decision Date1982-12-28
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DILULAB 230 is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823522. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILULAB 230?

DILULAB 230 is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Innovative Medical Systems, Inc.. The 510(k) number is K823522.

When did DILULAB 230 receive FDA 510(k) clearance?

DILULAB 230 received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823522.

Who is the listed applicant for DILULAB 230?

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

What is the FDA product code for DILULAB 230?

The FDA product code for DILULAB 230 is GKH.

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Other records listing Innovative Medical Systems, 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.

K973035VIOLA II DENTAL CAMERA SYSTEMK951469BAZOOKA SYSTEMK933184POSITIVE AIRWAY PRESSURE SYSTEMK924590MICROWAVE AUTOMATED TISSUE PROCESSORK922081LABOTECH AUTOMATED MICROTITER ANALYZERK921005AUTOLOADER

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Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K923530COULTER MULTI-Q-PREPCoulter Electronics, 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.

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