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FDA 510(k)

MI DAS 1000 AUTOMATIC SLIDE STAINER

K-Number: K821830 · 1982-07-22

ApplicantInnovative Medical Systems, Inc.
Decision Date1982-07-22
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MI DAS 1000 AUTOMATIC SLIDE STAINER 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 1982-07-22 under 510(k) number K821830. The device is classified under product code KPA. It was reviewed by the PA advisory panel. Product code KPA falls under the category of Cardiovascular, which encompasses devices for cardiovascular diagnosis, monitoring, and intervention. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MI DAS 1000 AUTOMATIC SLIDE STAINER?

MI DAS 1000 AUTOMATIC SLIDE STAINER is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Innovative Medical Systems, Inc.. The 510(k) number is K821830.

When did MI DAS 1000 AUTOMATIC SLIDE STAINER receive FDA 510(k) clearance?

MI DAS 1000 AUTOMATIC SLIDE STAINER received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821830.

Who is the listed applicant for MI DAS 1000 AUTOMATIC SLIDE STAINER?

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 MI DAS 1000 AUTOMATIC SLIDE STAINER?

The FDA product code for MI DAS 1000 AUTOMATIC SLIDE STAINER is KPA. This falls under the Cardiovascular category.

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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: KPA)

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.

K933996PROFIBLOTTecan U.S., Ltd.K884258VERSABLOTAmerican Bionetics, Inc.K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., 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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