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FDA 510(k)

CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS

K-Number: K904752 · 1991-04-12

ApplicantBoehringer Mannheim Corp.
Decision Date1991-04-12
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K904752. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS?

CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K904752.

When did CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS receive FDA 510(k) clearance?

CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS received FDA 510(k) clearance on 1991-04-12, under 510(k) number K904752.

Who is the listed applicant for CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS?

The FDA product code for CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS is JIR.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: JIR)

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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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