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FDA 510(k)

LABOTECH AUTOMATED MICROTITER ANALYZER

K-Number: K922081 · 1992-09-02

ApplicantInnovative Medical Systems, Inc.
Decision Date1992-09-02
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LABOTECH AUTOMATED MICROTITER ANALYZER 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 1992-09-02 under 510(k) number K922081. 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 LABOTECH AUTOMATED MICROTITER ANALYZER?

LABOTECH AUTOMATED MICROTITER ANALYZER is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Innovative Medical Systems, Inc.. The 510(k) number is K922081.

When did LABOTECH AUTOMATED MICROTITER ANALYZER receive FDA 510(k) clearance?

LABOTECH AUTOMATED MICROTITER ANALYZER received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922081.

Who is the listed applicant for LABOTECH AUTOMATED MICROTITER ANALYZER?

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 LABOTECH AUTOMATED MICROTITER ANALYZER?

The FDA product code for LABOTECH AUTOMATED MICROTITER ANALYZER is JJQ.

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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 PROCESSORK921005AUTOLOADERK915457PHACO 20/20 SYSTEM I

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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.

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