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FDA 510(k)

IRISTAIN FORMULA 2, PARTS 1 AND 2

K-Number: K893530 · 1989-06-13

ApplicantIntl. Remote Imaging Systems
Decision Date1989-06-13
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IRISTAIN FORMULA 2, PARTS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Remote Imaging Systems. It received FDA 510(k) clearance on 1989-06-13 under 510(k) number K893530. The device is classified under product code JTS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRISTAIN FORMULA 2, PARTS 1 AND 2?

IRISTAIN FORMULA 2, PARTS 1 AND 2 is a medical device that received FDA 510(k) clearance on 1989-06-13. The listed applicant is Intl. Remote Imaging Systems. The 510(k) number is K893530.

When did IRISTAIN FORMULA 2, PARTS 1 AND 2 receive FDA 510(k) clearance?

IRISTAIN FORMULA 2, PARTS 1 AND 2 received FDA 510(k) clearance on 1989-06-13, under 510(k) number K893530.

Who is the listed applicant for IRISTAIN FORMULA 2, PARTS 1 AND 2?

The FDA 510(k) record lists Intl. Remote Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRISTAIN FORMULA 2, PARTS 1 AND 2?

The FDA product code for IRISTAIN FORMULA 2, PARTS 1 AND 2 is JTS.

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Other records listing Intl. Remote Imaging Systems 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.

K022774IQ 200 SYSTEMK000373939UDX URINE PATHOLOGY SYSTEMK972141THE YELLOW IRIS URINALYSIS WORKSTATIONK953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZERK960054900UDX URINE PATHOLOGY SYSTEMK954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY

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Related Devices (Code: JTS)

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.

K960090CALCOFLUOR WHITE STAIN KITRemel Co.K960095BACTIDROP CALCOFLUOR WHITERemel Co.K920976BACTIDROP INDIA INKRemel Co.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K920970BACTIDROP KOH (10%)Remel Co.K890861ATS DOBELL & O'CONNOR'S IODINEAlpha-Tec Systems, 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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