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FDA 510(k)

PRECINORM IM AND PRECIPATH IM

K-Number: K860970 · 1986-04-03

ApplicantBoehringer Mannheim Corp.
Decision Date1986-04-03
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECINORM IM AND PRECIPATH IM 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 1986-04-03 under 510(k) number K860970. 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 PRECINORM IM AND PRECIPATH IM?

PRECINORM IM AND PRECIPATH IM is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K860970.

When did PRECINORM IM AND PRECIPATH IM receive FDA 510(k) clearance?

PRECINORM IM AND PRECIPATH IM received FDA 510(k) clearance on 1986-04-03, under 510(k) number K860970.

Who is the listed applicant for PRECINORM IM AND PRECIPATH IM?

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 PRECINORM IM AND PRECIPATH IM?

The FDA product code for PRECINORM IM AND PRECIPATH IM 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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