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FDA 510(k)

REFLOTRON CREATININE TEST TABS

K-Number: K913105 · 1991-08-12

ApplicantBoehringer Mannheim Corp.
Decision Date1991-08-12
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOTRON CREATININE TEST TABS 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 1991-08-12 under 510(k) number K913105. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOTRON CREATININE TEST TABS?

REFLOTRON CREATININE TEST TABS is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K913105.

When did REFLOTRON CREATININE TEST TABS receive FDA 510(k) clearance?

REFLOTRON CREATININE TEST TABS received FDA 510(k) clearance on 1991-08-12, under 510(k) number K913105.

Who is the listed applicant for REFLOTRON CREATININE TEST TABS?

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 REFLOTRON CREATININE TEST TABS?

The FDA product code for REFLOTRON CREATININE TEST TABS is JFY.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: JFY)

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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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