FDA 510(k)

PRECISET AMMONIA

K-Number: K843569 · 1984-09-28

Decision Date1984-09-28

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRECISET AMMONIA 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 1984-09-28 under 510(k) number K843569. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISET AMMONIA?

PRECISET AMMONIA is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K843569.

When did PRECISET AMMONIA receive FDA 510(k) clearance?

PRECISET AMMONIA received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843569.

Who is the listed applicant for PRECISET AMMONIA?

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 PRECISET AMMONIA?

The FDA product code for PRECISET AMMONIA is JJX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.