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FDA 510(k)

LINEARITY TEST KITS

K-Number: K912441 · 1991-07-17

ApplicantBoehringer Mannheim Corp.
Decision Date1991-07-17
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINEARITY TEST KITS 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 1991-07-17 under 510(k) number K912441. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINEARITY TEST KITS?

LINEARITY TEST KITS is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K912441.

When did LINEARITY TEST KITS receive FDA 510(k) clearance?

LINEARITY TEST KITS received FDA 510(k) clearance on 1991-07-17, under 510(k) number K912441.

Who is the listed applicant for LINEARITY TEST KITS?

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 LINEARITY TEST KITS?

The FDA product code for LINEARITY TEST KITS is JJY.

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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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