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FDA 510(k)

OLYMPUS URINE PH CALIBRATORS LEVELS I AND II

K-Number: K905477 · 1991-02-13

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-02-13
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS URINE PH CALIBRATORS LEVELS I AND II is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-02-13 under 510(k) number K905477. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS URINE PH CALIBRATORS LEVELS I AND II?

OLYMPUS URINE PH CALIBRATORS LEVELS I AND II is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K905477.

When did OLYMPUS URINE PH CALIBRATORS LEVELS I AND II receive FDA 510(k) clearance?

OLYMPUS URINE PH CALIBRATORS LEVELS I AND II received FDA 510(k) clearance on 1991-02-13, under 510(k) number K905477.

Who is the listed applicant for OLYMPUS URINE PH CALIBRATORS LEVELS I AND II?

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

What is the FDA product code for OLYMPUS URINE PH CALIBRATORS LEVELS I AND II?

The FDA product code for OLYMPUS URINE PH CALIBRATORS LEVELS I AND II is JIS.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JIS)

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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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